Use of nicotine replacement therapy in socioeconomically deprived young smokers: a community-based pilot randomised controlled trial.
ABSTRACT Smoking is common in young people, particularly in disadvantaged groups, and continued smoking has a major impact on quality and quantity of life. Although many young smokers want to stop smoking, little is known about the design and effectiveness of cessation services for them.
To determine whether nicotine replacement therapy (NRT) when combined with counselling is effective in young smokers in a deprived area of Nottingham, UK.
We surveyed smoking prevalence and attitudes to smoking and quitting in young people accessing an open access youth project in a deprived area of Nottingham, and used the information gained to design a community based smoking cessation service incorporating a randomised controlled trial of nicotine patches against placebo given in association with individual behavioural support. We resurveyed smoking prevalence among project attendees after completing the pilot study.
Of 264 young people surveyed (median age 14 years, range 11-21), 49% were regular smokers. A total of 98 young people were recruited and randomised to receive either active nicotine patches on a six week reducing dose regimen (49 participants), or placebo (49 participants). Adherence to therapy was low, the median duration being one week, and 63 participants did not attend any follow up. At four weeks, five subjects receiving active NRT and two receiving placebo were abstinent, and at 13 weeks none were. Adverse effects were more common in the active group but none were serious. Smoking prevalence among 246 youth project attendees surveyed after the trial was 44%.
This study suggests that NRT in this context is unlikely to be effective in young smokers, not least because of low adherence to therapy. It also suggests that young smokers want help with smoking cessation, but that establishing the efficacy of smoking cessation services for young people who need them most will be very difficult.
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ABSTRACT: 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.Cochrane database of systematic reviews (Online) 01/2012; · 5.94 Impact Factor
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ABSTRACT: The aim of this randomized, double-blind placebo-controlled clinical trial is to test the efficacy and safety of nicotine replacement therapy (NRT) in promoting end-of-treatment abstinence among adolescents and whether this relation is moderated by medication compliance. Participants (N=257, age: 16.7±1.13years) attended an information meeting followed by a 6- or 9-week treatment. Self-reported smoking cessation, compliance, and side effects were measured by means of online questionnaires. Intent-to-treat analyses showed that independent of compliance, NRT is effective in promoting abstinence rates after 2weeks (OR=2.02, 95% CI=1.11-3.69), but not end-of-treatment abstinence. However, end-of-treatment abstinence rates significantly increased in high-compliant (OR=1.09, 95% CI=1.01-1.17) and not in low-compliant participants. No serious adverse events were found. Future research is warranted to disentangle the process involving the decrease in abstinence rates and compliance rates from the third week after the quit date onwards.Journal of substance abuse treatment 09/2013; · 2.90 Impact Factor
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ABSTRACT: This field study tested an intervention that challenged beliefs about the effectiveness of various quit methods held by Salvation Army client smokers from two urban locations (N = 245). Data (surveys administered immediately after and one month post-intervention) were collected 2009-2010 and analyzed using primarily χ(2) and t-tests. The intervention changed client perceptions about the effectiveness of quitting methods. Compared to no-intervention controls, intervention participants reported significantly greater smoking reduction and greater likelihood of contacting the Wisconsin Tobacco Quit Line. Study implications/limitations are discussed and future research directions noted. This research was supported by grant UL1TR000427 from the Clinical and Translational Science Award (CTSA) program of the National Center for Advancing Translational Sciences, NIH.Substance Use & Misuse 02/2014; · 1.23 Impact Factor
Use of nicotine replacement therapy in socioeconomically
deprived young smokers: a community-based pilot
randomised controlled trial
Elin Roddy, Nick Romilly, Alison Challenger, Sarah Lewis, John Britton
............................................................... ............................................................... .
See end of article for
Dr Elin Roddy, Division of
Clinical Sciences Building,
Nottingham City Hospital,
Nottingham NG5 1PB, UK;
Received 21 September
Accepted 30 June 2006
Tobacco Control 2006;15:373–376. doi: 10.1136/tc.2005.014514
Background: Smoking is common in young people, particularly in disadvantaged groups, and continued
smoking has a major impact on quality and quantity of life. Although many young smokers want to stop
smoking, little is known about the design and effectiveness of cessation services for them.
Objective: To determine whether nicotine replacement therapy (NRT) when combined with counselling is
effective in young smokers in a deprived area of Nottingham, UK
Methods and subjects: We surveyed smoking prevalence and attitudes to smoking and quitting in young
people accessing an open access youth project in a deprived area of Nottingham, and used the
information gained to design a community based smoking cessation service incorporating a randomised
controlled trial of nicotine patches against placebo given in association with individual behavioural
support. We resurveyed smoking prevalence among project attendees after completing the pilot study.
Results: Of 264 young people surveyed (median age 14 years, range 11–21), 49% were regular smokers.
A total of 98 young people were recruited and randomised to receive either active nicotine patches on a
six week reducing dose regimen (49 participants), or placebo (49 participants). Adherence to therapy was
low, the median duration being one week, and 63 participants did not attend any follow up. At four
weeks, five subjects receiving active NRT and two receiving placebo were abstinent, and at 13 weeks none
were. Adverse effects were more common in the active group but none were serious. Smoking prevalence
among 246 youth project attendees surveyed after the trial was 44%.
Conclusions: This study suggests that NRT in this context is unlikely to be effective in young smokers, not
least because of low adherence to therapy. It also suggests that young smokers want help with smoking
cessation, but that establishing the efficacy of smoking cessation services for young people who need them
most will be very difficult.
Disadvantaged young people are more likely to become
lifelong smokers5–7and to smoke more heavily.8Although
self-reported motivation to quit is at least as high in
socioeconomically deprived smokers,9smoking cessation
rates have doubled in the most socially advantaged groups
over the past two decades but have not changed in the most
Despite the fact that most teenagers say that they want to
and many have tried and failed, the
prevalence of smoking among young people in Britain shows
no sign of falling, particularly among young women.12
Although adult smoking cessation services have become well
established in the UK since the government White Paper,13
there are still very few specialist cessation services for young
people. Those that are available tend to be bolted on to adult
cessation services, and as such are not perceived by many
young people to be acceptable.11 14The effectiveness of
nicotine replacement therapy (NRT) has not been established
in young smokers; open label trials15 16and one recent
placebo-controlled trial17have shown NRT to be well
tolerated but with no significant effect on smoking cessation.
We have carried out a placebo-controlled trial of the
acceptability and effectiveness of NRT, delivered in conjunc-
tion with individual or small group behavioural support, in
disadvantaged young people using an open-access youth
project in a deprived area of Nottingham.
moking is the biggest single preventable cause of
mortality and morbidity in the United Kingdom,1and
most smokers establish their addiction as teenagers.2–4
SUBJECTS AND METHODS
The Zone Youth Project is a relational voluntary sector youth
project based in a deprived area of inner city Nottingham and
was originally established to provide a resource for local
children who were not attending school. In cooperation with
local secondary schools, the Zone Project has developed a
rolling programme of issue-based work for local young
people, many of whom struggle to attend, or are excluded
from, full-time education. The project has an emphasis on
arts-based activities and an open-access sexual health
Community NHS Health Trust. This attracts a core group of
young people as well as a more transient group who are
involved on the fringes of the project.
In 2001, in response to requests for help with smoking
cessation from young smokers attending the Zone project, we
carried out a questionnaire survey of smoking prevalence and
smoking cessation service delivery preference in all young
people who accessed the Zone project in the month of
October. We also used the questionnaire responses to identify
young people interested in participating in the trial. We then
carried out qualitative work, comprising informal discussion
groups, one-to-one interviews and brainstorming activities
during group sessions, with young people and youth workers
to determine optimum methods of service delivery. We
established support services at the Zone based on the results
of the process and publicised these and our intention to carry
out a trial of NRT using flyers, posters and other novel
methods including street outreach, schools outreach and
Theatre in Education workshops. Recruitment and follow up
took place between March and December 2002 at an after
school drop-in cafe ´ run by the Zone youth project. We aimed
to recruit all attendees who were daily smokers; inclusion
and exclusion criteria are shown in table 1.
All consenting study participants were offered regular
behavioural counselling and were randomised using com-
puter generated randomisation codes in batches of 10 to
either active or placebo nicotine patches. Participants were
reviewed weekly by the study doctor for side effect
monitoring; patch dispensing and counselling was delivered
weekly on a one-to-one basis or in small friendship groups
by a Zone project youth worker trained in smoking
cessation, or a smoking cessation counsellor from the adult
smoking cessation service, in 10–15 minute sessions which
were offered at flexible times to suit the young people
involved. It was felt that 15 minutes was the optimum
length for sessions because of concentration span, although
this is less time than offered to adults receiving intensive
counselling. A behavioural counselling model was used18and
then refined to incorporate some motivational interviewing
techniques.19NRT was custom made (Stowic Resources Ltd,
Oxford, UK) to ensure identical active and placebo patches,
the active dose schedule being 15 mg/10 mg/5 mg for two
weeks each for a maximum of six weeks. Other forms of
NRT were not offered because of the lack of identical
placebos available. The researchers delivering NRT and
counselling were blind to the allocation of subjects. The
study code was broken for each individual at three months,
and up to six weeks of NRT offered to all continuing
smokers who received placebo. Primary outcome measures
were carbon monoxide validated quit rates at four and
13 weeks; secondary outcomes included reported adverse
effects and follow up rates.
intervention were conducted by the study doctor and
counsellor in one-to-one and friendship group settings
using a variety of techniques including flip chart listing
and pile-sorting exercises. In October 2002, we repeated the
initial questionnaire survey to assess any change in smoking
prevalence, knowledge of smoking
awareness of the intervention among all the young people
attending the project, some but not all of whom had been
surveyed in the initial questionnaire. The original power
calculation for the NRT trial was based on recruiting 550 of
the 1080 presumed young smokers in contact with the
youth project in to the trial, providing 90% power to detect
an increase from 15% cessation rates in the placebo group to
22% in the active group. These estimates proved to be
retention of study participants.
Initial questionnaire survey
In October 2001, we obtained valid questionnaires from 264
participants, recruited opportunistically from all available
Zone project attendees. Very few attendees declined to
participate, and 198 (75%) of respondents consented to
exhaled carbon monoxide (CO) measurement. The median
age (range) of respondents was 14.0 (11–21) years, 111
(42%) were male, and 129 (49%) were self-reported current,
regular smokers. Among the smokers the median CO reading
was 8 ppm (1–32), median Fagerstrom score 3.0 (0–7), and
the median number of cigarettes smoked per day was 10.
Most smokers (248; 94%) came from households with at least
one smoking adult; 84 (65%) of smokers reported that they
would like to quit smoking and 110 (85%) had made previous
unsuccessful attempts, giving up for an average of two weeks.
A total of 108 (84%) said that they would like the chance to
use some kind of NRT, with a preference for gum among the
girls and cutaneous patches among boys. Family support and
willpower rated highest among non-pharmacological aids
perceived to be helpful, with one-to-one support from a
counsellor also scoring highly. Young people indicated in
questionnaire responses and subsequent discussion groups
that they would prefer cessation support to be regular but
with flexible timings, held in a community setting and
offering counselling in one-to-one or small friendship groups.
Trial of NRT
A total of 145 young people volunteered for screening for the
NRT trial and 98 proved eligible and were randomised to
receive active or placebo patch. Inclusion criteria are shown
in table 1. There were no statistically significant differences
in baseline characteristics between subjects randomised to
active or placebo patches. Most attended as a result of word-
of-mouth publicity rather than direct advertisement of the
trial. All participants received behavioural counselling. The
median number of weeks of patch therapy with counselling
in those who attended following baseline was one week, and
eight young people (three active v five placebo) completed the
full six weeks of patch treatment. Most young people who
dropped out did so within the first two weeks of the study,
and over half of those who dropped out did so by not
attending follow up after initial screening and recruitment.
Of the 90 who did not complete patch therapy, two withdrew
because of adverse effects, two because they had quit
smoking, one because of a perception that the patches were
ineffective, and 22 because they changed their mind about
quitting. The remaining 63 did not attend further follow up,
so were presumed to be still smoking. At four weeks, five
subjects using active NRT and two subjects using placebo
achieved point abstinence (table 2). These subjects were
similar in age and addiction measures to those who were not
abstinent, but were more likely to be girls, to have been
initially ‘‘very interested’’ in quitting, and to have strong
parental and peer support to quit. At 13 weeks, no smokers
were abstinent. The nicotine patches were associated with
itching but there were few other adverse events (table 2).
Acceptability of intervention: qualitative assessments
A core group of young people, already involved with the work
of the youth project, attended all counselling sessions and
gave positive feedback. Other young people who were more
peripheral within the host project and who were recruited
opportunistically were more difficult to follow up.
Young people liked the fact that they could attend
autonomously without parental involvement, could talk with
a doctor in their own environment, and felt valued because
someone was concerned about their health and because of
the chance to use ‘‘adult’’ therapy, although many would
nicotine replacement therapy
Inclusion and exclusion criteria for trial of
Inclusion criteriaExclusion criteria
Aged 14–20 years and able to
Aged 12–14 and parental
Age ,12 or .20 years
Aged 12–14, or aged 14 or over but
not competent to consent, and parents
unable or unwilling to give consent
Self-reported non-smoker Regular smoker: .1 cigarette
per day (cpd) OR ,1 cpd but
past or anticipated withdrawal
Carbon monoxide validation
No medical contraindications
Allergic to sticking plaster
Pregnant or risk of pregnancy
374Roddy, Romilly, Challenger, et al
have liked the chance to use other forms of NRT. Young
people preferred to talk to a youth worker trained in smoking
cessation counselling than an adult smoking cessation
counsellor. Many young people did not realise how hard it
would be for them to quit and felt that it was unfair that half
of the study participants were given a ‘‘fake’’ patch.
Youth project staff found the intervention acceptable and
easy to publicise, and felt that it had increased their
confidence in raising smoking with young people and had
encouraged several of them to think about their own
smoking behaviour, and to quit smoking. We did not
approach parents directly for their views, but those who we
encountered gave positive feedback and several attended the
sessions in the hope of obtaining advice and NRT for
Follow up questionnaire
Similar numbers of questionnaires were returned in the
October 2002 survey (264 v 246) and there was similar gender
distribution, age (mean age 13.7 v 13.8 years) and mean CO
(5.46 v 5.3 ppm). Of those replying to the second survey, 64%
were aware of the smoking cessation project. There were
small but not significant differences in overall smoking
prevalence (49% v 44%) and plans for future quit attempts
(42% v 52%) regardless of whether individuals had accessed
This study was intended to assess the effectiveness of NRT in
young, disadvantaged smokers delivered in conjunction with
a customised cessation service designed in accordance with
their preferences. However, despite providing a service
tailored to the views of young people involved, the service
had low uptake and high dropout rates. Even though
recruitment to the study was lower than anticipated and
only small numbers were involved, there was little evidence
that NRT might be effective. The only potential positive
outcomes of the study were that NRT seemed safe in this
group, and overall prevalence of smoking in the targeted
community of young people decreased and stated intention
to quit smoking increased over the course of the study period,
suggesting that background increased awareness of smoking
as a health issue arising from the conduct of the study may
have had a positive impact.
This is the first published randomised controlled trial of
NRT in young people in the UK and the first in this
socioeconomic group. It is also the first published study to
have used a smoking cessation intervention designed
according to the views of young people for whom the service
was intended. Recruitment to the study was low for a
number of reasons: an overestimate on our part of the initial
smoking prevalence in this population, unwillingness of
young people to participate in a trial where half of
participants would get ‘‘nothing’’ (placebo), difficulty gain-
ing face-to-face consent from parents of 12–14 year olds, and
problems with non-attendance after a visit for initial screen-
ing. Dropout rates were high partly because of the general
characteristics of the young people taking part in the study,
but also because of difficulty in maintaining enthusiasm in
those who felt that they had placebo patches. Initial interest
was high but when a quit attempt failed young people were
not keen to come back and admit failure. Many were
surprised at how difficult they found it to abstain from
The low quit rates we achieved can be partly explained by
fluctuating motivation to quit in this group of young people,
low compliance with patch therapy, the strong influence of
peer and family smoking in this socioeconomic group, and
the easy availability to young people of cheap, smuggled
Compared with previous studies in the United States15–17
showing small but non-significant effects of NRT on
increasing quit rates in young smokers, our subjects were
younger, lighter smokers, with lower CO levels and addiction
measures, meaning that other influences may be more
important than nicotine addiction in continued smoking in
this group of young people. Because of the placebo nature of
the trial, we were not able to offer young people a choice of
nicotine preparations, and short-acting preparations such as
gum and inhalator may have fitted in well with patterns of
smoking in this group. In contrast to other studies, parental
involvement in the study was minimal, we did not offer any
form of financial incentive, and the project was entirely
community based. There were fewer adverse effects of NRT
when compared with previous studies.
In the event, our study was too small to detect an effect of
NRT on smoking cessation rates with appropriate power,
though if cessation had been as high as achievable in best
practice in adult smokers, we would have expected nine in
active and five in placebo to quit at one month. The fact that
only seven in total achieved this suggests that NRT and
counselling may be much less effective in younger age
groups. This may be because the young people we studied
were less addicted but had more social pressure to smoke,
which was not specifically addressed by this study. Young
people in this group may have found it more difficult than
adult smokers to stay motivated to quit smoking, and there
may be many other factors which we have not been able to
explore in this study.
The outcome of this and other studies indicates, however,
that the routine use of NRT in the form of patches for
underage smokers in this demographic is probably not
effective. Ideally, this issue needs to be addressed in larger
trials but our experience suggests that these will be difficult
to carry out, particularly against placebo, because of recruit-
ment and retention problems inherent in working with
versus placebo patches
Results of randomised controlled trial of nicotine
Mean age in years
Median exhaled CO (ppm)
CO validated point abstinence at 4 weeks
CO validated point abstinence at 13 weeks 0
Completed full six week treatment course
Withdrew because of adverse event
Other non-severe adverse events*
Pain or paraesthesia at patch site
Dizziness, nausea or headache
*Some participants experienced more than one adverse effect.
CO, carbon monoxide.
What this paper adds
Young smokers want to quit smoking and are keen to be able
to use NRT. Even with tailored, community based interven-
tions, adherence to patch therapy is low. Although patch
therapy was safe, it was not shown to be effective. Proving
the efficacy of smoking cessation interventions in young
people who need them most is difficult.
Use of NRT in socioeconomically deprived young smokers 375
disadvantaged young people. We may therefore never know
whether NRT is effective in young people, but this study
suggests not. In the absence of conclusive evidence, a
pragmatic approach offering a variety of nicotine replacement
preparations to young people who smoke more heavily could
We acknowledge the huge contribution of Rob Burton, former Zone
Youth Project co-ordinator. The entire project was funded by Cancer
Research UK. We acknowledge the contribution from all youth
workers, young people, parents and carers at the Zone Youth Project.
E Roddy, S Lewis, Division of Respiratory Medicine, School of Medical
and Surgical Sciences, University of Nottingham, UK
N Romilly, The Zone Youth Project, Aspley, Nottingham, UK
A Challenger, New Leaf Smoking Cessation Service, Nottingham, UK
J Britton, Division of Epidemiology and Public Health, School of
Community and Health Sciences, University of Nottingham, UK
Conflict of interests: There are no significant conflicts of interest.
Ethics approval: The study was approved by the Nottingham City
Hospital Research Ethics Committee.
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The Lighter Side.................................................................................
ENate Beeler, Washington Examiner.
376Roddy, Romilly, Challenger, et al