Effect of Nicotine Replacement Therapy on Agitation in Smokers With Schizophrenia: A Double-Blind, Randomized, Placebo-Controlled Study
ABSTRACT The authors conducted a randomized, placebo-controlled study of nicotine replacement therapy for the reduction of agitation and aggression in smokers with schizophrenia.
Participants were 40 smokers 18-65 years of age admitted to a psychiatric emergency service with a diagnosis of schizophrenia confirmed by the Mini International Neuropsychiatric Interview. Patients were screened for agitation with the excited component subscale of the Positive and Negative Syndrome Scale (PANSS) and for nicotine dependence with the Fagerström Test for Nicotine Dependence. A score of at least 14 on the PANSS excited component subscale and at least 6 on the Fagerström test were required for study eligibility. Participants in the nicotine replacement group received a 21-mg nicotine transdermal patch, and those in the placebo group were treated with a placebo patch. Participants received usual care with antipsychotics. The Agitated Behavior Scale and other agitation measures were administered at baseline and again at 4 and 24 hours.
At baseline, participants were at least moderately agitated, and 28% reported aggressive behavior in the previous week. The mean Agitated Behavior Scale score for the nicotine replacement group was 33% lower at 4 hours and 23% lower at 24 hours than for the placebo group. Participants with lower levels of nicotine dependence responded better than those with higher levels of dependence.
The drug-placebo difference in this study was similar to that obtained in trials of parenteral antipsychotics in similar populations. This finding suggests that in patients with schizophrenia, smoking status should be included in the assessment of agitation and nicotine replacement included in the treatment of those who are smokers.
SourceAvailable from: Colin P Mendelsohn
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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; DOI:10.1002/14651858.CD000146.pub4 · 5.94 Impact Factor
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ABSTRACT: Tobacco use results in numerous consequences for individuals with mental illnesses and other substance use disorders, yet it is not adequately addressed by behavioral health professionals, including psychiatrists. This column describes current inaction among behavioral health professionals and some possible reasons for it and recommends next steps. Psychiatrists should provide treatment for all patients with a co-occurring tobacco use disorder and provide leadership to change policies and practices in treatment centers. Psychiatrists can be vital leaders of the effort to reduce the toll of tobacco use among people with mental illnesses, addictions, or both. A national movement for addressing tobacco use in the behavioral health field can be galvanized if more psychiatrists participate.Psychiatric services (Washington, D.C.) 10/2014; 65(12). DOI:10.1176/appi.ps.201400235 · 2.81 Impact Factor