Effectiveness of Extended-Duration Transdermal Nicotine Therapy

Abstract

Background: Tobacco dependence is a chronic, relapsing condition that may require extended treatment. Objective: To assess whether extended transdermal nicotine therapy increases abstinence from tobacco more than standard duration therapy in adult smokers. Design: Parallel randomized placebo-controlled trial from September 2004 to February 2008 (small block randomization scheme, not stratified). Study participants and all research personnel except for the database manager were blinded to randomization. (NCT00364156) Setting: Academic center. Participants: 568 adult smokers. Intervention: Participants were randomized to: standard (8 weeks 21mg Nicoderm CQ, 16 weeks placebo) or extended (24 weeks 21mg Nicoderm CQ) therapy. Measurements: The primary outcome was biochemically-verified point prevalence abstinence at weeks 24 and 52. Secondary outcomes were continuous and prolonged abstinence, lapse and recovery events, cost/additional quitter, and side effects and adherence. Results: At 24 weeks, extended therapy produced higher rates of point prevalence abstinence (31.6% versus 20.3%; Odds Ratio [OR] = 1.81 [1.23-2.66], p = 0.002), prolonged abstinence (41.5% versus 26.9%; OR = 1.97 [1.38-2.82] p = 0.001), and continuous abstinence (19.2% versus 12.6%; OR = 1.64 [1.04-2.60] p = 0.032), versus standard therapy. Extended therapy reduced the risk for a lapse (Hazard Ratio [HR] = 0.77 [0.63-0.95], p = 0.013) and increased the chances of recovery from lapses (HR = 1.47 [1.17-1.84], p = 0.001). Time to relapse was slower with extended versus standard therapy (HR = 0.50 [0.35-0.73], p < 0.001). At week 52, extended therapy produced higher quit rates for prolonged abstinence only (p = 0.027). There were no group differences in side effects and adverse events at the extended treatment phase assessment. Limitations: The generalizability of the findings may be limited because participants were treatment-seeking smokers without medical comorbidity and differences in adherence across treatment arms were detected. Conclusion: Compared to 8 weeks of transdermal nicotine, 24 weeks of transdermal nicotine increased biochemically-confirmed point prevalence abstinence and continuous abstinence at week 24, reduced the risk of smoking lapses, and increased the likelihood of post-lapse recovery to abstinence.

Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study

“…67 Trials have also shown that extended use of NRT by ex-smokers may result in better long-term abstinence rates. 68,69 For this reason, NRT in the UK is licensed for smoking reduction, that is, dual use, and available to smokers who cannot or are unwilling to stop smoking completely, as a long-term harm reduction measure 70 NRT licensing is also being changed to allow its use for harm reduction purposes among ex-smokers. 71 Harm reduction refers to the reduced psychological or physiological harm from substance use without complete cessation.…”

High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine: A Proof of Concept Placebo-Controlled Trial

“…Side effects were assessed using a symptom checklist from past trials ( Schnoll et al, 2010 ). The checklist was administered at W eeks − 1, 0, 1, 3, 5, and 8.…”

“…At each assessment from W eek 0 -8, participants indicated if they used the patches on each day. Participants were classifi ed as compliant for a week if they used patches on 6 days or more each week ( Schnoll et al, 2010 ).…”

A Double-Blind Placebo-Controlled Randomized Trial of Varenicline for Smokeless Tobacco Dependence in India

“…Selfreported 7-day point prevalence abstinence was assessed at this time, and those who indicated abstinence were asked to attend clinic for biochemical confirmation of smokeless tobacco cessation with urinary cotinine (cutoff for abstinence ≤50 ng/ml; Benowitz et al, 2002) and absence of tobacco smoking using breath CO (>10 ppm). For lapse and recovery events, a smokeless-tobacco-use lapse was defined as any day between the quit date and EOT on which participants used smokeless tobacco; recovery was defined as any 24-hr period of self-reported abstinence postlapse (Schnoll et al, 2010;Wileyto et al, 2005). The outcome of interest was time to transition between runs of smokeless-tobacco-use days and runs of abstinent days.…”