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Background: Smoking is a global public health problem. For this reason, experts have called smoking dependence a global epidemic. Over the past 5 years, sales of electronic cigarettes, or e-cigarettes, have been growing strongly in many countries. Yet there is only partial evidence that e-cigarettes are beneficial for smoking cessation. In particular, although it has been proven that nicotine replacement devices may help individuals stop smoking and tolerate withdrawal symptoms, e-cigarettes' power to increase the quitting success rate is still limited, ranging from 5% to 20% dependent on smokers' baseline conditions as shown by a recent Cochrane review. Consequently, it is urgent to know if e-cigarettes may have a higher success rate than other nicotine replacement methods and under what conditions. Furthermore, the effects of the therapeutic setting and the relationship between individual characteristics and the success rate have not been tested. This protocol is particularly innovative, because it aims to test the effectiveness of electronic devices in a screening program (the COSMOS II lung cancer prevention program at the European Institute of Oncology), where tobacco reduction is needed to lower individuals' lung cancer risks. Objective: This protocol was designed with the primary aim of investigating the role of tobacco-free cigarettes in helping smokers improve lung health and either quit smoking or reduce their tobacco consumption. In particular, we aim to investigate the impact of a 3-month e-cigarettes program to reduce smoking-related respiratory symptoms (eg, dry cough, shortness of breath, mouth irritation, and phlegm) through reduced consumption of tobacco cigarettes. Furthermore, we evaluate the behavioral and psychological (eg, well-being, mood, and quality of life) effects of the treatment. Methods: This is a prospective, randomized, placebo-controlled, double-blind, three-parallel group study. The study is organized as a nested randomized controlled study with 3 branches: a nicotine e-cigarettes group, a nicotine-free e-cigarettes group, and a control group. The study is nested in a screening program for early lung cancer detection in heavy smokers. Results: The study is open and is still recruiting. Conclusions: Stopping or reducing tobacco consumption should be a main goal of any health organization. However, traditional antismoking programs are expensive and not always effective. Therefore, favoring a partial or complete shift to e-cigarettes in heavy smokers (eg, persons at high risk for a number of diseases) could be considered a moral imperative. However, before following this path, sound and reliable data on large samples and in a variety of contexts are required. Trial registration: Clinicaltrials.gov NCT02422914; https://clinicaltrials.gov/ct2/show/NCT02422914 (Archived by WebCite at http://www.webcitation.org/6etwz1bPL).
Content may be subject to copyright.
Original Paper
Benefits of E-Cigarettes Among Heavy Smokers Undergoing a
Lung Cancer Screening Program: Randomized Controlled Trial
Protocol
Claudio Lucchiari1, MS Psych, PhD (HK); Marianna Masiero2, PhD; Giulia Veronesi3, MD; Patrick Maisonneuve4,
MEng; Stefania Spina5, MPsych (Clin); Costantino Jemos6, PharmD; Emanuela Omodeo Salè6, PharmD; Gabriella
Pravettoni5,7, MS Psych, PhD (Psych)
1Università Degli Studi di Milano, Department of Philosophy, Milano, Italy
2Università Degli Studi di Milano, Health Sciences, Università Degli Studi di Milano, Milano, Italy
3European Institute of Oncology, Thoracic Devision, MIlan, Italy
4European Institute of Oncology, Division of Epidemiology and Biostatistics, MIlan, Italy
5European Institute of Oncology, Applied Research Unit for Cognitive and Psychological Science, MIlan, Italy
6European Institute of Oncology, Division of Pharmacy, Milan, Italy
7Università Degli Studi di Milano, Department of Oncology and Hemato-oncology, Milan, Italy
Corresponding Author:
Claudio Lucchiari, MS Psych, PhD (HK)
Università Degli Studi di Milano
Department of Philosophy
Via Festa del Perdono 7
Milano, 20122
Italy
Phone: 39 0250312240
Fax: 39 0250312241
Email: claudio.lucchiari@unimi.it
Abstract
Background: Smoking is a global public health problem. For this reason, experts have called smoking dependence a global
epidemic. Over the past 5 years, sales of electronic cigarettes, or e-cigarettes, have been growing strongly in many countries. Yet
there is only partial evidence that e-cigarettes are beneficial for smoking cessation. In particular, although it has been proven that
nicotine replacement devices may help individuals stop smoking and tolerate withdrawal symptoms, e-cigarettes’power to increase
the quitting success rate is still limited, ranging from 5% to 20% dependent on smokers’baseline conditions as shown by a recent
Cochrane review. Consequently, it is urgent to know if e-cigarettes may have a higher success rate than other nicotine replacement
methods and under what conditions. Furthermore, the effects of the therapeutic setting and the relationship between individual
characteristics and the success rate have not been tested. This protocol is particularly innovative, because it aims to test the
effectiveness of electronic devices in a screening program (the COSMOS II lung cancer prevention program at the European
Institute of Oncology), where tobacco reduction is needed to lower individuals’lung cancer risks.
Objective: This protocol was designed with the primary aim of investigating the role of tobacco-free cigarettes in helping
smokers improve lung health and either quit smoking or reduce their tobacco consumption. In particular, we aim to investigate
the impact of a 3-month e-cigarettes program to reduce smoking-related respiratory symptoms (eg, dry cough, shortness of breath,
mouth irritation, and phlegm) through reduced consumption of tobacco cigarettes. Furthermore, we evaluate the behavioral and
psychological (eg, well-being, mood, and quality of life) effects of the treatment.
Methods: This is a prospective, randomized, placebo-controlled, double-blind, three-parallel group study. The study is organized
as a nested randomized controlled study with 3 branches: a nicotine e-cigarettes group, a nicotine-free e-cigarettes group, and a
control group. The study is nested in a screening program for early lung cancer detection in heavy smokers.
Results: The study is open and is still recruiting.
Conclusions: Stopping or reducing tobacco consumption should be a main goal of any health organization. However, traditional
antismoking programs are expensive and not always effective. Therefore, favoring a partial or complete shift to e-cigarettes in
JMIR Res Protoc 2016 | vol. 5 | iss. 1 | e21 | p.1http://www.researchprotocols.org/2016/1/e21/ (page number not for citation purposes)
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heavy smokers (eg, persons at high risk for a number of diseases) could be considered a moral imperative. However, before
following this path, sound and reliable data on large samples and in a variety of contexts are required.
Trial Registration: Clinicaltrials.gov NCT02422914; https://clinicaltrials.gov/ct2/show/NCT02422914 (Archived by WebCite
at http://www.webcitation.org/6etwz1bPL)
(JMIR Res Protoc 2016;5(1):e21) doi:10.2196/resprot.4805
KEYWORDS
tobacco cessation; electronic cigarettes; lung cancer screening; smoking related diseases.
Introduction
The World Health Organization estimates that cigarette smoking
will claim the lives of 500 million people who are alive today
and as many as 1 billion people during the 21st century.
Although clinical therapies for smoking cessation have proven
effective, the long-term abstinence rate remains low.
Electronic cigarettes, which are also known as tobacco-free
cigarettes or e-cigarettes, are battery-operated devices that
vaporize a liquid solution of propylene glycol and/or vegetable
glycerin in which nicotine and/or flavors are dissolved. A recent
review of the field showed that e-cigarettes may be considered
safe, with few adverse effects and limited toxicity [1].
The value of these tools is that they reduce the risk of
smoking-related diseases. However, while the use of e-cigarettes
in heavy smokers will reduce the risk of tobacco-related cancers,
their role in antismoking programs has not yet been approved.
The World Health Organization and the US Food and Drug
Administration have promoted the launch of research on this
field of study, but study results are not convergent.
In a prospective study, e-cigarettes were shown to substantially
decrease the consumption of tobacco cigarettes without causing
significant side effects [2]. In the study, reductions in the number
of cigarettes smoked per day and breath carbon monoxide (CO)
levels were observed at each visit in all study groups, with no
consistent differences among them. Furthermore, rapid
improvement in breathing symptoms was observed.
However, most participants continued smoking or started
smoking again; after 1 year, fewer than 10% remained abstinent.
This is probably due to the research targeting smokers who did
not intend to quit. As suggested by Remo and colleagues [3],
we argue that much better results might be achieved in smokers
motivated to quit.
From a physiological point of view, e-cigarettes appear to
eliminate the craving for tobacco in the same way as nicotine
replacement therapy (NRT). In an overview of the Cochrane
Library [4] that considered studies globally—including more
than 50,000 smokers—NRT was described as being particularly
efficacious for the short term (3 months) but less so in the long
term (12 months). However, the use of NRT increases the
success rate of quitting attempts independent of the setting if
compared to attempts made by smokers on their own or
supported only by counseling. Furthermore, NRT is particularly
useful for smokers who are prepared to quit, but who have high
nicotine dependence. Eventually, NRT will be particularly
effective when smokers’ baseline conditions are predictors of
successful quitting. Comparing the conclusion of the Cochrane
review with the results of studies on e-cigarettes effects, it is
clear that in some cases the sample used was quite different
from the one used in most trials on NRT. We argue that it is
necessary to study e-cigarettes efficacy while also considering
population baseline characteristics as well as psycho-cognitive
parameters. Indeed, we can expect smokers who are not prepared
to quit or in psychosocial conditions associated with a low
success rate (ie, mood disturbance, living in a context with high
prevalence of tobacco cigarettes smokers, low-income status)
to report a worse outcome in studies using e-cigarettes as
tobacco cessation treatment [2,4].
Previous research has stressed that monitoring lifestyle
parameters (in particular, physical activity and sleep quality)
and acting on them could help maintain abstinence. In particular,
physical exercise may aid smokers in the first 3 months, while
longer effects are less clear [5]. It has been observed that regular
physical activity among smokers reduces nicotine withdrawal
symptoms and craving. Last, smoking during the night is an
indicator of nicotine dependence and predicts failure in smoking
cessation [6]. Sleep disturbances have several negative
psychological effects, including reduced quality of life and
psychological distress (ie, anxiety and depression). Low sleep
quality due to abstinence is a predictor of a poor smoking
treatment outcome [7].
Low-cost, noninvasive devices are now available to monitor
lifestyle parameters. These electronic bracelets are reliable and
easy to use. Counseling approaches based on similar tools have
been shown to improve outcomes [8].
This protocol may also address a number of psychological
parameters, in order to determine whether individual features
might hamper behavioral changes and related positive effects
on health. Indeed, heavy smokers have specific psycho-cognitive
traits [9]. In particular, they generally show higher levels of
impulsiveness than nonsmokers. At the same time, smokers
tend to have a high level of activity in the behavioral activation
system (BAS). It has been suggested that high BAS sensitivity
is involved in addictive behaviors like smoking. Individuals
with high BAS are more inclined to enact approaching behaviors
and experience positive effects when they receive positive
rewards.
This study offers an opportunity to test the effectiveness of
e-cigarettes in a clinically controlled setting, in order to reduce
tobacco consumption and improve health benefits. Furthermore,
the protocol is nested in a screening program for early detection
of lung cancer at the European Institute of Oncology (IEO)
called COSMOS II (Continuous Observation of SMOking
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Subjects) that will allow subject recruitment and continuous
monitoring. The COSMOS II project aims to improve early
diagnosis of lung cancer, which is currently considered to be
the most important life-saving tool. This is an Italian program,
coordinated by IEO and created to identify an optimal
personalized protocol for early diagnosis in people with a high
risk of lung cancer (ie, heavy smokers or former smokers over
the age of 55). The COSMOS II program will enroll 10,000
heavy smokers or former smokers throughout Italy. COSMOS
II derives from the previous successful COSMOS I screening
project [10,11].
The main hypothesis is based on previous research on the effect
of e-cigarette use in substitution of tobacco cigarettes. We
hypothesize that the reduction of cigarette tobacco consumption
leads to a significant decrease of cough, breath shortness, and
other respiratory symptoms at 6 months. This reduction will
improve the quality of life and well-being. Furthermore, we
expect this effect to be higher for smokers using nicotine
e-cigarettes and support than for a placebo group and
support-only group. This would be coherent with previous
research on NRT and e-cigarettes. Indeed, we argue that smokers
who are both motivated to start a quitting attempt and aware of
smoking-related risks yet continue consuming several tobacco
cigarettes a day need an integrated antismoking strategy that
combines physiological, behavioral, and psychological
interventions. The use of electronic cigarettes, providing both
physiological and behavioral replacement of tobacco cigarette
consumption, and low-intensity counseling, providing
psychological support, might then be an optimal strategy in
these cases.
Eventually, we expect particular psychological conditions to
be associated with better outcomes. In particular, we hypothesize
that participants with a low level of depression, an active
lifestyle, and a low BAS will find the use of e-cigarettes more
advantageous.
Methods
Objectives
The main objective was to evaluate the impact of a 3-month
e-cigarettes program to reduce smoking-related respiratory
symptoms (eg, dry cough, breath shortness, mouth irritation,
and phlegm) as a consequence of reduced tobacco cigarette
consumption. Secondary objectives were to (1) assess the
success rate of smoking cessation attempts in the three groups;
(2) monitor safety and toxicity during the study; (3) evaluate
psychological and behavioral (ie, lifestyle) effects of
e-cigarettes; (4) assess the impact of e-cigarette use on quality
of life; and (5) identify cognitive/behavioral patterns as
e-cigarettes success predictors in reducing tobacco cigarette
smoking.
More specifically, the main aim of the project concerns the
effectiveness of e-cigarettes in improving lung health in the
heavy smokers involved in the COSMOS II program. If proven
safe and effective, e-cigarettes should be included in lung cancer
screening programs as a standard tool to reduce smoking-related
risks for lung diseases. Naturally, this aim requires a scientific
approach, since e-cigarettes should not increase nicotine
dependence. Another fundamental aim of the project regards
the effectiveness of e-cigarettes in reducing tobacco
consumption. In particular, no studies to date have tested the
feasibility and effectiveness of these tools in limiting risky
behaviors (eg, tobacco smoking) among heavy smokers enrolled
in a lung cancer screening program. Consequently, we want to
determine whether providing e-cigarettes to participants in a
controlled protocol reduces tobacco consumption, as well as
related health and breathing problems. We also aim to analyze
the psychological characteristics and needs of the subjects
enrolled in the COSMOS II program, in order to evaluate how
risk perception (eg, the premise of risky behavior adoption) is
associated with a psycho-cognitive profile. We argue that an
important and successful screening project, such as COSMOS,
should incorporate a comprehensive approach to the individual.
Design
This is a prospective, randomized, placebo-controlled,
double-blind, three-parallel group study. The study protocol
was designed using the recommendations of the Consolidated
Standards of Reporting Trials statement (Figure 1).
For this study, we opted for the VP5 electronic cigarettes kit,
which offered a good quality/price ratio and proven reliability
and safety. Nicotine and nicotine-free liquids are produced by
BioFumo, which fully collaborated with us and provided liquids
in nicotine concentrations of 8 mg/mL and packages that were
not distributed for commercial use.
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Figure 1. CONSORT flow diagram.
Participants
Volunteer smokers are recruited from among COSMOS II
participants at the IEO hospital. Details on the inclusion and
exclusion criteria are provided in the “Selection Criteria” section
below.
The main inclusion criterion is adult healthy smokers who
voluntarily choose to take part in a lung cancer screening
program. This screening program includes both a low-dose
computed tomography (CT) scan and blood tests in order to
detect early signs of lung cancer. Consequently, all of our
participants agree to undergo these examinations and are over
the age of 55 at the beginning of the study. To be included in
the study, COSMOS II participants must have smoked an
average of 10 cigarettes or more a day for at least the past 10
years. Furthermore, they also must report strong motivation to
stop smoking as measured by a motivational questionnaire (see
the “Instruments and Measures” section).
Since we are interested in assessing the effect of a specific
e-cigarettes-based treatment, we exclude smokers already using
e-cigarettes, which we define as smokers who had ever regularly
used e-cigarettes for more than 1 week alone or in combination
with tobacco cigarettes. Thus, all participants are inexperienced
with the use of e-cigarettes (full instructions are provided by
the researcher in charge of the study during the briefing). Also,
smokers who at the moment of the interview are undergoing
NRT or underwent NRT in the previous 6 months are excluded.
In this way, we tried to prevent any psychological and
physiological confounding effects due to previous treatments.
Furthermore, people with a history of psychiatric, severe
dyspnea, and cardiovascular diseases are also excluded.
All the including and excluding criteria are evaluated during
the first clinical examination of the COSMOS II program. Only
after the clinical examination, which includes objective tests
and an anamnestic interview by a physician in charge, is a
smoker considered for possible inclusion in the protocol.
Selection Criteria
Inclusion Criteria
1. Subjects are involved in the COSMOS II study
2. Subjects have smoked at least ten cigarettes a day for the
past 10 years
3. Subjects wish to reduce tobacco smoking (motivational
score higher than 10) who are not treated at a smoking
center
4. Signed informed consent
Exclusion Criteria
1. Symptomatic cardiovascular disease
2. Symptomatic severe respiratory disease
3. Regular psychotropic medication use
4. Current or past history of alcohol abuse
5. Use of smokeless tobacco or NRT
6. Participation in another antismoking program in the current
year
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Treatments
Group 1 Treatment (E-Cigarette and Support)
The participants receive an e-cigarettes kit and 12 10-mL liquid
cartridges containing an 8 mg/mL concentration of nicotine.
They are instructed to use the electronic cigarette ad libitum
during the first week before their quitting day (determined at
the first contact) in order to familiarize themselves with its use.
Starting at Week 2 (soon after the designated quitting day), the
participants are asked to stop smoking tobacco cigarettes and
use the e-cigarettes exclusively for the next 11 weeks.
E-cigarette use is monitored through a weekly paper diary and
regular telephone interviews. Since it is not possible to exclude
tobacco-cigarette smoking after the quit day, the weekly diary
also contains items related to cigarette smoking. Tobacco
smoking is also addressed during the periodic calls.
During treatment, a low-intensity remote (by phone) counseling
program is provided to maintain motivation and monitor any
psychological and/or physical problems related to the study
protocols. This program includes 4 calls in total, 1 at the ends
of Week 1, Week 4, Week 8, and Week 12. Each call will last
about 10 minutes; will address concerns about any ongoing
psychological, physical, and behavioral changes; and will
support the participants’ continued motivation by providing
practical suggestions.
The participants also receive an electronic fitness bracelet in
order to assess their physical activity and sleep quality during
treatment.
Group 2 Treatment (Placebo)
The participants receive an e-cigarettes kit and 12 10-mL
nicotine-free liquid cartridges. This liquid has the same
manufacturer, flavor, and components (except for nicotine) as
the one used in Group 1. All other procedures and measures
used for Group 2 are the same as those for Group 1.
Group 3 Treatment (Control/Support-Only)
The participants are provided only with low-intensity remote
(by phone) antismoking counseling to motivate and support
cigarette smoking cessation and abstinence. Scheduling, aims,
and structure are the same as those of Group 1. The participants
also receive an electronic fitness bracelet in order to assess their
physical activity and sleep quality during treatment. All
measures and procedures are identical to Groups 1 and 2.
Treatments Common to All Groups
A complete explanation of the project and informed
participant consent
Baseline behavioral, motivational, and psycho-cognitive
evaluation (set of questionnaires)
Baseline clinical parameter assessment
Initial and final face-to-face interview
Regular telephone interviews
Explanation of the weekly short-diary procedure
Briefing on and delivery of the e-bracelet
Low-intensity remote smoking cessation counseling
program
Instruments and Measures
Clinical Parameter Evaluation
Anamnesis
Clinical examination
CO measurement
Low-dose CT scan
Circulating micro-RNA examination
Respiratory examination
Instruments
Self-reported measures are used for cough and other
respiratory symptoms assessment. We opted for Likert
scales to measure cough, breath shortness, mouth irritation,
and phlegm frequency as well as the Leicester Cough
Questionnaire.
Fagerstrom Test for Nicotine Dependence: a 6-item
self-reporting questionnaire assessing nicotine dependence.
It requires a few minutes to complete [12]. This test is
administered to all COSMOS II participants.
Motivational questionnaire [13]: a 4-item self-reporting
questionnaire assessing motivation to quit smoking. The
total classifies the patient into 1 of 4 motivational categories
(from “not ready to quit” to “highly motivated”). This test
is administered to all COSMOS II participants.
Hospital Anxiety and Depression Scale (HAD): The HAD
is a self-administered questionnaire composed of two 7-item
scales, 1 for anxiety and 1 for depression, which should be
used as 2 separate measures of emotional distress. The scale
has been validated for Italian culture by Costantini and
showed high internal consistency with Crohnbach alpha,
ranging from .83 to .85 [14]. The HAD evaluates symptoms
of anxiety and depression, avoiding misattribution due to
the physical aspects of the illness. The values range from
0 to 21 for each scale. Cutoff scores are preliminarily
defined as normal (0-5), mild (6-8), moderate (9-11), and
severe (greater than 11) for both anxiety and depression
patients [15].
BIS/BAS Scale [16]: a 20-item self-reporting questionnaire
evaluating the behavioral inhibition system (BIS) and BAS.
Each of the items is rated on a 5-point scale, ranging from
1 (does not describe me at all) to 5 (describes me very well).
Barratt Scale [17]: an 11-item self-reporting questionnaire
designed to measure impulsiveness. All items are measured
on a 4-point scale (Rarely/Never; Occasionally; Often;
Almost Always/Always), where a 4 generally indicates the
most impulsive response, although some items are scored
in reverse order to avoid a response bias [18].
The Leicester Cough Questionnaire: a valid, self-reported
cough-specific health status measure. It is a 19-item
questionnaire that has been validated in acute and chronic
cough [19]. The overall score ranges from 3 to 21 with a
higher score indicating a better quality of life.
Electronic bracelet (the Flex FitBit): a device that allows
lifestyle monitoring of physical activity and sleep
characteristics, including: sleeping and napping (hours slept,
light vs deep sleep, and waking periods); activity (distance,
calories burned, activity time, and activity intensity);
nutrition (food and beverage intake); mood (assessment of
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the affect state); and an insight engine that identifies hidden
connections and patterns in day-to-day activities.
The exhaled CO is measured by the The Micro+
Smokerlyzer, which has less than 5% H2cross-sensitivity.
Ad hoc questionnaire: measures demographic data,
self-perceived quality of life (analogue scale), physical
activity, and smoking-related issues (characteristics of the
smoking experience).
Recruitment and Follow-Up
All inclusion and exclusion criteria are checked during the
registration procedure and initial assessment for inclusion in
COSMOS II. Eligible participants are asked to provide informed
consent. The informed consent form is signed and dated by both
the participant and the physician. Enrolled participants receive
a chronological number and are assigned to a treatment group
(e-cigarettes with nicotine, e-cigarettes without nicotine, or
control).
A randomization list using a permuted block design (40 blocks
of 6 subjects randomly assigned to 1 of the 3 treatment groups)
have been previously prepared by an independent personnel
unit and labeled with the progressive number applied to the
packaging containing e-cigarettes and liquid cartridges with or
without nicotine (Group 1 and Group 2).
Neither the participant nor the researcher in charge knows
whether the liquid in the e-cigarettes kit contains nicotine. Only
the statistician who prepared the randomization list and the
person labeling the e-cigarettes packaging know the actual
treatment.
Each participant is then assigned to one of the three groups and
receives the related treatment, as illustrated above.
Follow-up: 6 months (at the IEO)
Behavioral psycho-cognitive questionnaires
Clinical parameters assessment (respiratory symptoms)
Smoking status assessment (questionnaire and CO level).
The nonsmoking status is established by self-report items
and the CO level (ppm<5).
Debriefing, during which we also ask participants of Group
1 and Group 2 to guess if they used a nicotine-free or a
nicotine-based e-cigarette.
End-point: 12 months (at the IEO, during the annual assessment
of COSMOS II)
Clinical parameter assessment (respiratory symptoms)
Final behavioral and psycho-cognitive assessment
Smoking status assessment (questionnaire and CO level)
Debriefing and collection of comments
Timeline (Figure 2):
Distribution of e-cigarettes: 3 months (ends at Week 12)
Data tracking (e-bracelet) and active monitoring: 6 months
(ends at Week 24)
End point: 12 months
Figure 2. Protocol plan.
Endpoints/Evaluation Criteria
Primary Outcome Measures
Change in respiratory symptoms (eg, dry cough, breath
shortness, mouth irritation)
To evaluate the impact of a 3-month e-cigarettes program to
reduce smoking-related respiratory symptoms (dry cough, breath
shortness, mouth irritation, and phlegm) through reduced
tobacco cigarette consumption. The primary outcome is
measured at Month 6 and then at the follow-up at Month 12.
Secondary Outcome Measures
Change in psychological well-being (HAD scale)
Change in number of cigarettes smoked daily
Change in the concentration of exhaled air CO
Change in daily activity (mean number of daily steps)
Change in lifestyle as measured by ad-hoc questionnaires
Statistical Considerations
Sample Size
Starting with data provided by previous studies on the effect of
smoking discontinuation, whether using or not using e-cigarettes
[2,20,21], we expected to find a reduction between 20% and
30% of respiratory symptoms reported by participants. We used
cough as the measure to power the trial on. Using a two-sided
Ztest, a sample of 70 participants in either of the experimental
groups (e-cigarettes with or without nicotine) and 70 in the
control group (counseling alone) will reach 80% power, at .05
significance level, to detect a 20% reduction in the frequency
of symptoms from the baseline in either of the e-cigarette groups
(with or without nicotine) compared to a 5% reduction in the
control group (counseling alone).
Statistical Plan
The main analysis will consist of comparing the reduction in
symptoms after 6 months for the three groups: e-cigarettes with
nicotine vs control; e-cigarettes without nicotine vs control; and
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e-cigarettes with nicotine versus e-cigarettes without nicotine.
Analyses will be based on two-sided Ztests.
A secondary analysis will assess the reduction of the
consumption of tobacco-containing cigarettes after 6 months
among the groups. Analysis will be based on paired Student’s
t-test or the Wilcoxon signed rank tests.
No interim monitoring is planned since, given the sample size,
any interim analysis would have too few events to be interpreted.
Efforts will be made to maximize retention by maximizing trust
at the baseline assessment and collecting multiple means to
contact and commit participants, including email and phone
contact details, and by assertive follow-up. Starting with our
previous experience with a similar population coming from the
COSMOS I program, we expect that our participants will be
compliant with and committed to the aims of the study. Giving
the expected intrinsic motivation of participants and thanks to
the above strategies, the study aims to have at least 80%
retention at 6 months and 70% at 12 months. Considering these
figures, we expect to maintain a statistical power to detect a
reduction of 5 cigarettes/day in our smokers (the cigarettes per
day mean is about 20 in the COSMOS population). Thus, using
a two-sided two-sample t-test with a significance level (alpha)
of .05, a sample size of 49 participants per arm will achieve
80% power to detect a mean reduction of 5 cigarettes/day
between any of the 2 experimental arms and the control arm,
assuming a mean consumption of 20 cigarettes/day in the control
arm and a common standard deviation of 8.7.
Ethical Considerations
This study is performed in accordance with the principles stated
in the Declaration of Helsinki and subsequent amendments, and
in accordance with the Good Clinical Practice Guideline. This
protocol was assessed and certified by the ethical board of
Fondazione Umberto Veronesi, the ethical committee of
Università degli studi di Milano, and the ethical committee of
the European Institute of Oncology. The ClinicalTrials.gov
identifier is NCT02422914. Informed consent will be obtained
from all subjects.
Results
At the time of manuscript submission, the trial’s status is
“recruiting.”
Discussion
Principal Findings
Cigarette smoking is a major risk factor for a variety of diseases.
The World Health Organization states that tobacco kills nearly
6 million people each year and that an annual death toll of more
than 8 million is expected by 2030.
Despite the availability of approved medications and smoking
cessation aids (ie, NRT, bupropion, varenicline, and counseling
programs), long-term quitting rates are relatively low. Most
smokers try to quit without professional help even when they
see their doctor on a regular basis. Indeed, smoking status is
rarely documented and smoking cessation treatments are offered
even less frequently [22], wasting an opportunity provided by
the doctor-patient relationship.
The failure of tobacco control is clear in developing countries.
However, in most rich countries, tobacco control also is
problematic due to a number of factors. Economic and ethical
issues often conflict in antismoking research and strategies [23],
and the relatively recent availability on the market of e-cigarettes
has added further confusion [24]. Consequently, independent
studies are needed in this field to avoid any possible external
influence. Furthermore, we believe that lung cancer screening
programs (like COSMOS II, where this project is nested) have
an ethical obligation to provide participants access to all the
information and strategies that could help them to reduce their
risk. Stopping or reducing tobacco consumption, then, should
be a primary goal. However, traditional antismoking programs
are expensive and not always effective. Therefore, favoring a
partial or complete shift to e-cigarettes in heavy smokers (eg,
persons at high risk for a number of diseases) could be
considered a moral imperative. However, to follow this path,
sound and reliable data is required on a large sample and in a
variety of contexts.
Last, the question of the use of e-cigarettes and their regulation
concerns not only physiological and toxicity aspects (eg, the
association between cancer and smoking), but also certain
relevant behavioral and psychological aspects as well. Thus, it
is necessary not only to understand the toxicity of these new
ways of smoking, but also their impact on smokers’ minds and
lifestyles.
Conclusions
E-cigarettes-based intervention could provide a gateway to
boosting health-related behavior changes, in order to reduce
tobacco consumption and positively impact smokers’ quality
of life. Indeed, reducing tobacco consumption or supporting
abstinence could be considered a fundamental aim of a screening
program, since a change in smoking habits reduces the risk of
smoking-related diseases.
Recent studies [2,3,25] show that e-cigarettes must be
considered safe devices that are potentially useful both for
reducing clinical symptoms (eg, cough, phlegm, breath
shortness) and enhancing the impact of antismoking
interventions. Consequently, the use of e-cigarettes is
particularly important in prevention programs and for high-risk
subjects. Many aspects are currently unclear and debated [25].
Hence, the outcome of this study will provide important data
on the possible role of e-cigarettes as tools for use in screening
and prevention programs. We argue that e-cigarettes apply a
medicalized substitution logic in which nicotine dependence
becomes a route to health in addition to a disorder to be treated.
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Acknowledgments
This work is supported by Fondazione Umberto Veronesi. The sponsor of the study is the University of Milan (Università degli
studi di Milano, Italy), which monitors the scientific, legal, and ethical aspects of the study. Subjects are recruited at an Italian
cancer center, the IEO, located in Milan. Methodological support is provided by the Interdisciplinary Research and Intervention
Centre of the University of Milan and the IEO Division of Epidemiology and Biostatistics. IEO’s central pharmacy is responsible
for assigning, allocating, and delivering e-cigarettes liquids. This work is supported by a grant from Fondazione Umberto Veronesi
(FUV).
Nicotine and nicotine-free liquids are produced by BioFumo, which offered full collaboration to meet the study demands. In
particular, BioFumo provided us with the liquids with nicotine concentration of 8 mg/mL in packages that were not distributed
for commercial use. All devices and products (eg, e-cigarettes, liquids, electronic bracelets) are purchased thanks to economic
support provided by the FUV. No support is provided to the study by tobacco industries or other for-profit corporations.
We are grateful to IEO personnel for their help in organizing and managing the study, as well as for their contribution to
methodological and ethical aspects.
Authors' Contributions
CL, MM, GP, PM, and GV conceived of and designed the study. CL coordinated the study, CL and CP acquired legal authorizations,
and MM and SS managed participants. Statistical support and data management were provided by PM and RB, while e-cigarettes
and liquids were managed by JC and EOS. Drafting and writing of the manuscript was handled by CL, MM, and PM. All authors
have read and approved the final manuscript.
Conflicts of Interest
None declared.
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Abbreviations
BAS: behavioral approach system
BIS: behavioral inhibition system
CT: computed tomography
CO: carbon monoxide
COSMOS: Continuous Observation of SMOking Subjects
HAD: Hospital Anxiety and Depression Scale
IEO: European Institute of Oncology
NRT: nicotine replacement therapy
Edited by G Eysenbach; submitted 05.06.15; peer-reviewed by P Krebs, N Walker; comments to author 16.07.15; revised version
received 07.08.15; accepted 07.10.15; published 03.02.16
Please cite as:
Lucchiari C, Masiero M, Veronesi G, Maisonneuve P, Spina S, Jemos C, Omodeo Salè E, Pravettoni G
Benefits of E-Cigarettes Among Heavy Smokers Undergoing a Lung Cancer Screening Program: Randomized Controlled Trial Protocol
JMIR Res Protoc 2016;5(1):e21
URL: http://www.researchprotocols.org/2016/1/e21/
doi:10.2196/resprot.4805
PMID:26842790
©Claudio Lucchiari, Marianna Masiero, Giulia Veronesi, Patrick Maisonneuve, Stefania Spina, Costantino Jemos, Emanuela
Omodeo Salè, Gabriella Pravettoni. Originally published in JMIR Research Protocols (http://www.researchprotocols.org),
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03.02.2016. This is an open-access article distributed under the terms of the Creative Commons Attribution License
(http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium,
provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information,
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... ab 18 Jahre, 18-70 Jahre). Leider ging in die Metaanalyse nur eine Studie mit Schwerpunkt auf Ältere ab 55 Jahren ein, die zum einen Personen mit kardiovaskulären oder respiratorischen Vorerkrankungen oder mit regulärer Medikamenteneinnahme ausschloss und die zum anderen nur geringen bis keinen Nutzen der nikotinhaltigen E-Zigarette im Vergleich zur nikotinfreien E-Zigarette plus Beratung aufwies (Lucchiari et al., 2016;Lucchiari et al., 2020;Masiero et al., 2019;Masiero et al., 2020;NCT02422914, 2015). Eine kürzlich erschienene Metaanalyse von Wang und Kollegen (2021) fand Belege für einen zusätzlichen Nutzen von E-Zigaretten in der Rauchentwöhnung, wenn diese kostenlos angeboten und in den jeweiligen Versuchsgruppen zusätzliche Informationen zur Tabakentwöhnung (Halpern et al., 2018) oder zur Unterstützung von Verhaltensänderungen (Hajek et al., 2019;Lucchiari et al., 2020;Walker et al., 2020;Wang/Bhadriraju/Glantz, 2021) angeboten wurden. ...
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DO SENIORS’ VAPE OR SMOKE? COMPARISON OF SMOKING AND VAPING IN THE OLDER POPULATION IN 26 EUROPEAN COUNTRIES AND ISRAEL. DATA FROM THE SHARE SURVEY 2019/ 2020 (WAVE 8) Significance. Currently, only moderately informative data on the use of e-cigarettes and tobacco products are available for Europe’s oldest population. The present study describes the distribution of e-cigarette and tobacco product use in the elderly population in 26 European countries and Israel. Methods. Wave 8 (release 1.0.0) of the SHARE Survey on Health, Aging and Retirement in Europe served as data basis. A total of n = 46,077 persons aged 50 years and older (42.6 percent male, 57.4 percent female) were interviewed about their smoking behavior. The mean age was 71.3 years (minimum = 50 years, maximum = 104 years). For the extrapolation to the population, we used calibrated cross-sectional weights. Results. Overall, the sample’s prevalence for e-cigarette use was 0.45 percent (extrapolated to 811,000 persons aged 50 and above in the 26 European countries and Israel). The proportion of e-cigarette users was found to decline with age. Among those aged 50 to 69, 0.64 percent (extrapolated to 725,000) used e-cigarettes; among those aged 70 to 79, 0.16 percent (extrapolated to 62,000) used e-cigarettes; and among those aged 80 and older, 0.1 percent (extrapolated to 23,000) used e-cigarettes. The overall prevalence for the use of tobacco products was 43.9 percent in the sample (extrapolated to 80 million). Tobacco product use also declined as age increased. For example, among those aged 50 to 69, 49.1 percent (extrapolated to 55 million) used tobacco products; among those aged 70 to 79, 41.3 percent (extrapolated to 17 million) used tobacco products; and among those aged 80 and older, 27.7 percent (extrapolated to 8 million) used tobacco products. Conclusion. As of late 2020, e-cigarette use is far from a mass phenomenon among older persons. However, it could become significant if it were suitable for the cessation of the more widespread tobacco smoking.
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Background: Smoking rates have declined over the last half-century, however, e-cigarette use has more than tripled in the recent years. Tobacco-risk education and tobacco-free policies are critical policy instruments to help prevent youth tobacco use. This study evaluates the impact of these policies on youth cigarette and e-cigarette use. Methods: Data from the 2013/2015 Georgia Youth Tobacco Survey (GYTS) is used to test for statistical differences in tobacco use status across school-based tobacco control policies and estimate their impact on cigarette and e-cigarette use. Data includes 5,285 participants representing 2013 middle school (n=2,099), 2013 high school (n=1,775), and 2015 high school (n=1,411). Current cigarette and e-cigarette use is measured as having used them in the past month. Students were asked if their school has a tobacco-free policy and if they were taught in classes about why they should not use tobacco. Multivariate logistic regression and Chi-squared tests are used to analyze data. Results: The use of cigarettes among high school students has decreased, however the use of e-cigarettes has increased. Strong statistical associations exist between tobacco-use behavior and tobacco-control policies, however, these associations were not consistent across all cohorts. Smoking disparities exist where males, White and Hispanic students smoked at much higher rates. Conclusions: The rise of e-cigarette popularity may have significant health effects and become a gateway to smoking cigarettes. The positive impact of tobacco-free policies on youth cigarette use is counter-intuitive and may be the result of adoption of tobacco-free policies by the schools where tobacco use is of a significant concern, hence, higher smoking rates. Future research should examine the effects of these policies, their enforcement, and length of existence in detail to provide more evidence into the effectiveness of these policies.
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Background: Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e-liquid. Some people who smoke use ECs to stop or reduce smoking, but some organizations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit and if they are safe to use for this purpose. This is an update conducted as part of a living systematic review. Objectives: To examine the effectiveness, tolerability, and safety of using electronic cigarettes (ECs) to help people who smoke tobacco achieve long-term smoking abstinence. Search methods: We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO to 1 May 2021, and reference-checked and contacted study authors. We screened abstracts from the Society for Research on Nicotine and Tobacco (SRNT) 2021 Annual Meeting. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and randomized cross-over trials, in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. Studies had to report abstinence from cigarettes at six months or longer or data on safety markers at one week or longer, or both. Data collection and analysis: We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow-up, adverse events (AEs), and serious adverse events (SAEs). Secondary outcomes included the proportion of people still using study product (EC or pharmacotherapy) at six or more months after randomization or starting EC use, changes in carbon monoxide (CO), blood pressure (BP), heart rate, arterial oxygen saturation, lung function, and levels of carcinogens or toxicants or both. We used a fixed-effect Mantel-Haenszel model to calculate risk ratios (RRs) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data in meta-analyses. Main results: We included 61 completed studies, representing 16,759 participants, of which 34 were RCTs. Five of the 61 included studies were new to this review update. Of the included studies, we rated seven (all contributing to our main comparisons) at low risk of bias overall, 42 at high risk overall (including all non-randomized studies), and the remainder at unclear risk. There was moderate-certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.53, 95% confidence interval (CI) 1.21 to 1.93; I2 = 0%; 4 studies, 1924 participants). In absolute terms, this might translate to an additional three quitters per 100 (95% CI 1 to 6). There was low-certainty evidence (limited by very serious imprecision) that the rate of occurrence of AEs was similar (RR 0.98, 95% CI 0.80 to 1.19; I2 = 0%; 2 studies, 485 participants). SAEs were rare, but there was insufficient evidence to determine whether rates differed between groups due to very serious imprecision (RR 1.30, 95% CI 0.89 to 1.90: I2 = 0; 4 studies, 1424 participants). There was moderate-certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non-nicotine EC (RR 1.94, 95% CI 1.21 to 3.13; I2 = 0%; 5 studies, 1447 participants). In absolute terms, this might lead to an additional seven quitters per 100 (95% CI 2 to 16). There was moderate-certainty evidence of no difference in the rate of AEs between these groups (RR 1.01, 95% CI 0.91 to 1.11; I2 = 0%; 3 studies, 601 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 1.06, 95% CI 0.47 to 2.38; I2 = 0; 5 studies, 792 participants). Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.61, 95% CI 1.44 to 4.74; I2 = 0%; 6 studies, 2886 participants). In absolute terms this represents an additional six quitters per 100 (95% CI 2 to 15). However, this finding was of very low certainty, due to issues with imprecision and risk of bias. There was some evidence that non-serious AEs were more common in people randomized to nicotine EC (RR 1.22, 95% CI 1.12 to 1.32; I2 = 41%, low certainty; 4 studies, 765 participants), and again, insufficient evidence to determine whether rates of SAEs differed between groups (RR 1.51, 95% CI 0.70 to 3.24; I2 = 0%; 7 studies, 1303 participants). Data from non-randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate with continued use. Very few studies reported data on other outcomes or comparisons, hence evidence for these is limited, with CIs often encompassing clinically significant harm and benefit. Authors' conclusions: There is moderate-certainty evidence that ECs with nicotine increase quit rates compared to NRT and compared to ECs without nicotine. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the effect size. Confidence intervals were for the most part wide for data on AEs, SAEs and other safety markers, with no difference in AEs between nicotine and non-nicotine ECs. Overall incidence of SAEs was low across all study arms. We did not detect evidence of harm from nicotine EC, but longest follow-up was two years and the number of studies was small. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates, but further RCTs are underway. To ensure the review continues to provide up-to-date information to decision-makers, this review is now a living systematic review. We run searches monthly, with the review updated when relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.
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Background: Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e-liquid. Some people who smoke use ECs to stop or reduce smoking, but some organizations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit and if they are safe to use for this purpose. This is an update of a review first published in 2014. Objectives: To examine the effectiveness, tolerability, and safety of using electronic cigarettes (ECs) to help people who smoke achieve long-term smoking abstinence. Search methods: We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO to 1 February 2021, together with reference-checking and contact with study authors. Selection criteria: We included randomized controlled trials (RCTs) and randomized cross-over trials in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. To be included, studies had to report abstinence from cigarettes at six months or longer and/or data on adverse events (AEs) or other markers of safety at one week or longer. Data collection and analysis: We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow-up, adverse events (AEs), and serious adverse events (SAEs). Secondary outcomes included changes in carbon monoxide, blood pressure, heart rate, blood oxygen saturation, lung function, and levels of known carcinogens/toxicants. We used a fixed-effect Mantel-Haenszel model to calculate the risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data from these studies in meta-analyses. Main results: We included 56 completed studies, representing 12,804 participants, of which 29 were RCTs. Six of the 56 included studies were new to this review update. Of the included studies, we rated five (all contributing to our main comparisons) at low risk of bias overall, 41 at high risk overall (including the 25 non-randomized studies), and the remainder at unclear risk. There was moderate-certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.69, 95% confidence interval (CI) 1.25 to 2.27; I2 = 0%; 3 studies, 1498 participants). In absolute terms, this might translate to an additional four successful quitters per 100 (95% CI 2 to 8). There was low-certainty evidence (limited by very serious imprecision) that the rate of occurrence of AEs was similar) (RR 0.98, 95% CI 0.80 to 1.19; I2 = 0%; 2 studies, 485 participants). SAEs occurred rarely, with no evidence that their frequency differed between nicotine EC and NRT, but very serious imprecision led to low certainty in this finding (RR 1.37, 95% CI 0.77 to 2.41: I2 = n/a; 2 studies, 727 participants). There was moderate-certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non-nicotine EC (RR 1.70, 95% CI 1.03 to 2.81; I2 = 0%; 4 studies, 1057 participants). In absolute terms, this might again lead to an additional four successful quitters per 100 (95% CI 0 to 11). These trials mainly used older EC with relatively low nicotine delivery. There was moderate-certainty evidence of no difference in the rate of AEs between these groups (RR 1.01, 95% CI 0.91 to 1.11; I2 = 0%; 3 studies, 601 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 0.60, 95% CI 0.15 to 2.44; I2 = n/a; 4 studies, 494 participants). Compared to behavioral support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.70, 95% CI 1.39 to 5.26; I2 = 0%; 5 studies, 2561 participants). In absolute terms this represents an increase of seven per 100 (95% CI 2 to 17). However, this finding was of very low certainty, due to issues with imprecision and risk of bias. There was no evidence that the rate of SAEs differed, but some evidence that non-serious AEs were more common in people randomized to nicotine EC (AEs: RR 1.22, 95% CI 1.12 to 1.32; I2 = 41%, low certainty; 4 studies, 765 participants; SAEs: RR 1.17, 95% CI 0.33 to 4.09; I2 = 5%; 6 studies, 1011 participants, very low certainty). Data from non-randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate with continued use. Very few studies reported data on other outcomes or comparisons and hence evidence for these is limited, with confidence intervals often encompassing clinically significant harm and benefit. Authors' conclusions: There is moderate-certainty evidence that ECs with nicotine increase quit rates compared to ECs without nicotine and compared to NRT. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the size of effect, particularly when using modern EC products. Confidence intervals were for the most part wide for data on AEs, SAEs and other safety markers, though evidence indicated no difference in AEs between nicotine and non-nicotine ECs. Overall incidence of SAEs was low across all study arms. We did not detect any clear evidence of harm from nicotine EC, but longest follow-up was two years and the overall number of studies was small. The evidence is limited mainly by imprecision due to the small number of RCTs, often with low event rates. Further RCTs are underway. To ensure the review continues to provide up-to-date information, this review is now a living systematic review. We run searches monthly, with the review updated when relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.
Article
Importance It has been estimated that in 2018 nearly 20% of adults in the US were currently using a tobacco product. Objective To systematically review the effectiveness and safety of pharmacotherapy, behavioral interventions, and electronic cigarettes for tobacco cessation among adults, including pregnant persons, to inform the US Preventive Services Task Force. Data Sources PubMed, PsycInfo, Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, Centre for Reviews and Dissemination of Health Technology Assessment; surveillance through September 25, 2020. Study Selection Systematic reviews of tobacco cessation interventions and randomized clinical trials that evaluated the effects of electronic cigarettes (e-cigarettes) or pharmacotherapy among pregnant persons. Data Extraction and Synthesis Independent critical appraisal and data abstraction; qualitative synthesis and random-effects meta-analyses. Main Outcomes and Measures Health outcomes, tobacco cessation at 6 months or more, and adverse events. Results Sixty-seven reviews addressing pharmacotherapy and behavioral interventions were included as well as 9 trials (N = 3942) addressing e-cigarettes for smoking cessation and 7 trials (N = 2285) of nicotine replacement therapy (NRT) use in pregnancy. Combined pharmacotherapy and behavioral interventions (pooled risk ratio [RR], 1.83 [95% CI, 1.68-1.98]), NRT (RR, 1.55 [95% CI, 1.49-1.61]), bupropion (RR, 1.64 [95% CI, 1.52-1.77]), varenicline (RR, 2.24 [95% CI, 2.06-2.43]), and behavioral interventions such as advice from clinicians (RR, 1.76 [95% CI, 1.58-1.96]) were all associated with increased quit rates compared with minimal support or placebo at 6 months or longer. None of the drugs were associated with serious adverse events. Five trials (n = 3117) reported inconsistent findings on the effectiveness of electronic cigarettes on smoking cessation at 6 to 12 months among smokers when compared with placebo or NRT, and none suggested higher rates of serious adverse events. Among pregnant persons, behavioral interventions were associated with greater smoking cessation during late pregnancy (RR, 1.35 [95% CI, 1.23-1.48]), compared with no intervention. Rates of validated cessation among pregnant women allocated to NRT compared with placebo were not significantly different (pooled RR, 1.11 [95% CI, 0.79-1.56], n = 2033). Conclusions and Relevance There is strong evidence that a range of pharmacologic and behavioral interventions, both individually and in combination, are effective in increasing smoking cessation in nonpregnant adults. In pregnancy, behavioral interventions are effective for smoking cessation, but data are limited on the use of pharmacotherapy for smoking cessation. Data on the effectiveness and safety of electronic cigarettes for smoking cessation among adults are also limited and results are inconsistent.
Article
Background: Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e-liquid. People who smoke report using ECs to stop or reduce smoking, but some organisations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit and if they are safe to use for this purpose. This review is an update of a review first published in 2014. Objectives: To evaluate the effect and safety of using electronic cigarettes (ECs) to help people who smoke achieve long-term smoking abstinence. Search methods: We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO for relevant records to January 2020, together with reference-checking and contact with study authors. Selection criteria: We included randomized controlled trials (RCTs) and randomized cross-over trials in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. To be included, studies had to report abstinence from cigarettes at six months or longer and/or data on adverse events (AEs) or other markers of safety at one week or longer. Data collection and analysis: We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow-up, AEs, and serious adverse events (SAEs). Secondary outcomes included changes in carbon monoxide, blood pressure, heart rate, blood oxygen saturation, lung function, and levels of known carcinogens/toxicants. We used a fixed-effect Mantel-Haenszel model to calculate the risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data from these studies in meta-analyses. Main results: We include 50 completed studies, representing 12,430 participants, of which 26 are RCTs. Thirty-five of the 50 included studies are new to this review update. Of the included studies, we rated four (all which contribute to our main comparisons) at low risk of bias overall, 37 at high risk overall (including the 24 non-randomized studies), and the remainder at unclear risk. There was moderate-certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.69, 95% confidence interval (CI) 1.25 to 2.27; I2 = 0%; 3 studies, 1498 participants). In absolute terms, this might translate to an additional four successful quitters per 100 (95% CI 2 to 8). There was low-certainty evidence (limited by very serious imprecision) of no difference in the rate of adverse events (AEs) (RR 0.98, 95% CI 0.80 to 1.19; I2 = 0%; 2 studies, 485 participants). SAEs occurred rarely, with no evidence that their frequency differed between nicotine EC and NRT, but very serious imprecision led to low certainty in this finding (RR 1.37, 95% CI 0.77 to 2.41: I2 = n/a; 2 studies, 727 participants). There was moderate-certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non-nicotine EC (RR 1.71, 95% CI 1.00 to 2.92; I2 = 0%; 3 studies, 802 participants). In absolute terms, this might again lead to an additional four successful quitters per 100 (95% CI 0 to 12). These trials used EC with relatively low nicotine delivery. There was low-certainty evidence, limited by very serious imprecision, that there was no difference in the rate of AEs between these groups (RR 1.00, 95% CI 0.73 to 1.36; I2 = 0%; 2 studies, 346 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 0.25, 95% CI 0.03 to 2.19; I2 = n/a; 4 studies, 494 participants). Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.50, 95% CI 1.24 to 5.04; I2 = 0%; 4 studies, 2312 participants). In absolute terms this represents an increase of six per 100 (95% CI 1 to 14). However, this finding was very low-certainty, due to issues with imprecision and risk of bias. There was no evidence that the rate of SAEs varied, but some evidence that non-serious AEs were more common in people randomized to nicotine EC (AEs: RR 1.17, 95% CI 1.04 to 1.31; I2 = 28%; 3 studies, 516 participants; SAEs: RR 1.33, 95% CI 0.25 to 6.96; I2 = 17%; 5 studies, 842 participants). Data from non-randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate over time with continued use. Very few studies reported data on other outcomes or comparisons and hence evidence for these is limited, with confidence intervals often encompassing clinically significant harm and benefit. Authors' conclusions: There is moderate-certainty evidence that ECs with nicotine increase quit rates compared to ECs without nicotine and compared to NRT. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the degree of effect, particularly when using modern EC products. Confidence intervals were wide for data on AEs, SAEs and other safety markers. Overall incidence of SAEs was low across all study arms. We did not detect any clear evidence of harm from nicotine EC, but longest follow-up was two years and the overall number of studies was small. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates. Further RCTs are underway. To ensure the review continues to provide up-to-date information for decision-makers, this review is now a living systematic review. We will run searches monthly from December 2020, with the review updated as relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.
Chapter
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The purpose of the present study was to revise the Barratt Impulsiveness Scale Version 10 (BIS-10), identify the factor structure of the items among normals, and compare their scores on the revised form (BIS-11) with psychiatric inpatients and prison inmates. The scale was administered to 412 college undergraduates, 248 psychiatric inpatients, and 73 male prison inmates. Exploratory principal components analysis of the items identified six primary factors and three second-order factors. The three second-order factors were labeled Attentional Impulsiveness, Motor Impulsiveness, and Nonplanning Impulsiveness. Two of the three second-order factors identified in the BIS-11 were consistent with those proposed by Barratt (1985), but no cognitive impulsiveness component was identified per se. The results of the present study suggest that the total score of the BIS-11 is an internally consistent measure of impulsiveness and has potential clinical utility for measuring impulsiveness among selected patient and inmate populations.
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We used electronic health record (EHR) data to determine rates and patient characteristics in offering cessation interventions (counseling, medications, or referral) and initiating quit attempts. Ten community health centers in New York City contributed 30 months of de-identified patient data from their EHRs. Of 302 940 patients, 40% had smoking status recorded and only 34% of documented current smokers received an intervention. Women and younger patients were less likely to have their smoking status documented or to receive an intervention. Patients with comorbidities that are exacerbated by smoking were more likely to have status documented (82.2%) and to receive an intervention (52.1%), especially medication (10.8%). Medication, either alone (odds ratio [OR] = 1.9; 95% confidence interval [CI] = 1.5, 2.3) or combined with counseling (OR = 1.8; 95% CI = 1.5, 2.3), was associated with higher quit attempts compared with no intervention. Data from EHRs demonstrated underdocumentation of smoking status and missed opportunities for cessation interventions. Use of data from EHRs can facilitate quality improvement efforts to increase screening and intervention delivery, with the potential to improve smoking cessation rates. (Am J Public Health. Published online ahead of print April 16, 2015: e1-e7. doi:10.2105/AJPH.2014.302444).
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Several empirical studies have shown the attitude of smokers to formulate judgments based on distortion in the risk perception. This alteration is produced by the activation of the optimistic bias characterized by a set of the unrealistic beliefs compared to the outcomes of their behavior. This bias exposes individuals to adopt lifestyles potentially dangerous for their health, underestimate the risks and overestimate the immediate positive effects. This study aimed to analyze the relationship between optimistic bias and smoking habits. In particular, it was hypothesized that smokers develop optimistic illusions, able to facilitate the adoption and the maintenance over time of the unhealthy lifestyles, such as cigarette smoking, and the former smokers could acquire a belief system centered on own responsibility. The samples (n = 633, female = 345, male = 288) composed of smokers (35.7%), ex-smokers (32.2%) and nonsmokers (32.1%). Each participant filled out two questionnaires including The Fagerström test and the motivational questionnaire as well as a set of items measured on a Likert scales to evaluate health beliefs. The results confirmed the presence of the optimistic bias in comparative judgments, and the attitude to overestimate the effectiveness of their preventive behaviors in the smokers. Cognitive bias in risk perception may influence health behaviors in negative way and reinforce cigarette smoking over the time. Future research should be conducted to identify the better strategies to overtake this cognitive bias to improve the quitting rate.
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Electronic cigarettes are a recent development in tobacco harm reduction. They are marketed as less harmful alternatives to smoking. Awareness and use of these devices has grown exponentially in recent years, with millions of people currently using them. This systematic review appraises existing laboratory and clinical research on the potential risks from electronic cigarette use, compared with the well-established devastating effects of smoking tobacco cigarettes. Currently available evidence indicates that electronic cigarettes are by far a less harmful alternative to smoking and significant health benefits are expected in smokers who switch from tobacco to electronic cigarettes. Research will help make electronic cigarettes more effective as smoking substitutes and will better define and further reduce residual risks from use to as low as possible, by establishing appropriate quality control and standards.
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Gray (1981, 1982) holds that 2 general motivational systems underlie behavior and affect: a behavioral inhibition system (BIS) and a behavioral activation system (BAS). Self-report scales to assess dispositional BIS and BAS sensitivities were created. Scale development (Study 1) and convergent and discriminant validity in the form of correlations with alternative measures are reported (Study 2). In Study 3, a situation in which Ss anticipated a punishment was created. Controlling for initial nervousness, Ss high in BIS sensitivity (assessed earlier) were more nervous than those low. In Study 4, a situation in which Ss anticipated a reward was created. Controlling for initial happiness, Ss high in BAS sensitivity (Reward Responsiveness and Drive scales) were happier than those low. In each case the new scales predicted better than an alternative measure. Discussion is focused on conceptual implications.
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Background Electronic cigarettes (e-cigarettes) can deliver nicotine and mitigate tobacco withdrawal and are used by many smokers to assist quit attempts. We investigated whether e-cigarettes are more eff ective than nicotine patches at helping smokers to quit.
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Background: We aimed to examine prevalence and correlates of past-month electronic cigarette ("e-cigarette") use and use of e-cigarettes to aid a cessation attempt in three samples of young adult smokers recruited online in 2009-2010 (Study 1), 2010-2011 (Study 2), and 2013 (Study 3). Methods: Participants were young adults aged 18 to 25 who smoked at least one cigarette in the previous month (Study 1, N=1987 and Study 2, N=570) or smoked 3 or more days each week and used Facebook 4 or more days per week (Study 3, N=79). We examined both past-month e-cigarette use and ever use of e-cigarettes to quit conventional cigarettes. Results: Prevalence of past-month use of e-cigarettes was higher in each subsequent study: Study 1 (6%), Study 2 (19%), and Study 3 (41%). In multivariate analyses, significant correlates of past-month e-cigarette use were identified for Study 1 (male sex OR=2.1, p=.03; past-year quit attempt OR=1.6, p=.03) and Study 2 (male sex, OR=1.7, p=.03; younger age OR=0.88, p=.05), but not Study 3. In multivariate analyses, significant correlates of ever use of e-cigarette to quit conventional cigarettes were identified for Study 1 (education, OR=1.2, p=.02; smoking within 30min of waking, OR=2.8, p=.02; past year quit attempt OR=4.1, p=.02), and Study 3 (desire to quit smoking, OR=1.3, p=.02), but not Study 2. Conclusions: E-cigarette use is increasingly common among young adults, particularly men. E-cigarette use for quitting conventional cigarettes appears more common among those more nicotine dependent and interested in quitting.
Article
Background: The aim of nicotine replacement therapy (NRT) is to temporarily replace much of the nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence. Objectives: The aims of this review were: To determine the effect of NRT compared to placebo in aiding smoking cessation, and to consider whether there is a difference in effect for the different forms of NRT (chewing gum, transdermal patches, oral and nasal sprays, inhalers and tablets/lozenges) in achieving abstinence from cigarettes. To determine whether the effect is influenced by the dosage, form and timing of use of NRT; the intensity of additional advice and support offered to the smoker; or the clinical setting in which the smoker is recruited and treated. To determine whether combinations of NRT are more likely to lead to successful quitting than one type alone. To determine whether NRT is more or less likely to lead to successful quitting compared to other pharmacotherapies. Search methods: We searched the Cochrane Tobacco Addiction Group trials register for papers mentioning 'NRT' or any type of nicotine replacement therapy in the title, abstract or keywords. Date of most recent search July 2012. Selection criteria: Randomized trials in which NRT was compared to placebo or to no treatment, or where different doses of NRT were compared. We excluded trials which did not report cessation rates, and those with follow-up of less than six months. Data collection and analysis: We extracted data in duplicate on the type of participants, the dose, duration and form of nicotine therapy, the outcome measures, method of randomization, and completeness of follow-up. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. We calculated the risk ratio (RR) for each study. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed-effect model. Main results: We identified 150 trials; 117 with over 50,000 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The risk ratio (RR) of abstinence for any form of NRT relative to control was 1.60 (95% confidence interval [CI] 1.53 to 1.68). The pooled RRs for each type were 1.49 (95% CI 1.40 to 1.60, 55 trials) for nicotine gum; 1.64 (95% CI 1.52 to 1.78, 43 trials) for nicotine patch; 1.95 (95% CI 1.61 to 2.36, 6 trials) for oral tablets/lozenges; 1.90 (95% CI 1.36 to 2.67, 4 trials) for nicotine inhaler; and 2.02 (95% CI 1.49 to 2.73, 4 trials) for nicotine nasal spray. One trial of oral spray had an RR of 2.48 (95% CI 1.24 to 4.94). The effects were largely independent of the duration of therapy, the intensity of additional support provided or the setting in which the NRT was offered. The effect was similar in a small group of studies that aimed to assess use of NRT obtained without a prescription. In highly dependent smokers there was a significant benefit of 4 mg gum compared with 2 mg gum, but weaker evidence of a benefit from higher doses of patch. There was evidence that combining a nicotine patch with a rapid delivery form of NRT was more effective than a single type of NRT (RR 1.34, 95% CI 1.18 to 1.51, 9 trials). The RR for NRT used for a short period prior to the quit date was 1.18 (95% CI 0.98 to 1.40, 8 trials), just missing statistical significance, though the efficacy increased when we pooled only patch trials and when we removed one trial in which confounding was likely. Five studies directly compared NRT to a non-nicotine pharmacotherapy, bupropion; there was no evidence of a difference in efficacy (RR 1.01; 95% CI 0.87 to 1.18). A combination of NRT and bupropion was more effective than bupropion alone (RR 1.24; 95% CI 1.06 to 1.45, 4 trials). Adverse effects from using NRT are related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. There is no evidence that NRT increases the risk of heart attacks. Authors' conclusions: All of the commercially available forms of NRT (gum, transdermal patch, nasal spray, inhaler and sublingual tablets/lozenges) can help people who make a quit attempt to increase their chances of successfully stopping smoking. NRTs increase the rate of quitting by 50 to 70%, regardless of setting. The effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the individual. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT.
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The World Health Organisation (WHO) recently commissioned a report reviewing evidence on electronic cigarettes and making policy recommendations. A version of it was subsequently published as an academic paper. We identify important errors in the description and interpretation of the studies reviewed, and find many of its key conclusions misleading. Free access for 1 month at: http://onlinelibrary.wiley.com/doi/10.1111/add.12730/pdf