Varenicline for smoking cessation among methadone-maintained smokers: A randomized clinical trial

Abstract

Background With smoking rates far exceeding the general population, methadone-maintained (MMT) opiate-dependent smokers experience high rates of tobacco-related health consequences. Previous treatment studies have used nicotine replacement and produced low quit rates. Methods We test, using a three-group randomized design, the efficacy of varenicline vs. placebo, in comparison with nicotine replacement therapy (NRT) that combines nicotine patch prescription plus ad libitum nicotine rescue, for smoking cessation. We recruited methadone-maintained smokers from nine treatment centers in southern New England and provided six months of treatment, and a minimal behavioral intervention at baseline (NCI's 5A's). Outcomes included carbon monoxide (CO) confirmed 7-day point smoking cessation prevalence at 6 months and self-reported change in mean cigarettes per day. Results The 315 participants had a mean age of 40, with 50% male and 79% non-Hispanic White, smoked an average of 19.6 (± 10.4) cigarettes / day, and had a mean daily methadone dose of 109 mg. Intent-to-treat analyses, with missing considered to be smoking, showed the rate of CO-confirmed 7-day abstinence at 6-months was 5.4% overall, with varenicline 3.7% compared to placebo 2.2%, and NRT 8.3% (p>.05). Adherence rates during the 7-days immediately prior to 6-month assessment were 34.2% in varenicline, 34.4% in placebo, and 48.8% in NRT. Between baseline and 6-months there was an overall self-reported mean reduction of 8.3 cigarettes / day. Conclusion Varenicline did not increase quit rates over placebo. Smoking cessation rates in methadone-maintained smokers are low and novel treatment strategies are required.

Varenicline and Adverse Cardiovascular Events: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

“…After the removal of duplicates and screening of titles and abstracts, 68 trials underwent full‐text review. In total, 38 RCTs met all eligibility criteria and were included in our meta‐analysis 10, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49…”

Early Quit Days Among Methadone-Maintained Smokers in a Smoking Cessation Trial

“…Quit initiation is an area that has not been well studied among MMT smokers. As noted previously, the existing RCTs of smoking cessation among MMT populations report on longer term follow-up outcomes and do not emphasize the early stages of the quitting in their analyses (Haug et al, 2004;Shoptaw et al, 2002;Stein et al, 2006Stein et al, , 2013, which will be examined in the current investigation.…”

“…In the trial by Stein et al (2006) comparing Motivational Interviewing (MI) plus NRT to brief advice and patch, the intent-to-treat CO-confirmed 7-day point prevalence estimate of cessation were 5.2% in the MI group and 4.7% in the brief advice group at 6 months. Subsequent trial by Stein et al (2013) testing NRT, varenicline, and varenicline placebo also showed poor rates of CO-confirmed 7-day abstinence rates at 6-month follow-up (5.4%) and there were no treatment group differences found (varenicline group abstinence = 3.7%, placebo 2.2%, and NRT 8.3%). Similarly, in the trial by Haug et al (2004), there were no treatment group difference between the Motivational Enhancement Therapy group and the standard care control in abstinence rates at follow-up (1-3 months).…”

“…Therefore, our study aims focus on predictors of an early quit attempt. We utilize baseline and early treatment outcome data from a threegroup randomized controlled trial testing the efficacy of varenicline against varenicline placebo and NRT (Stein et al, 2013). We will describe the incidence of early quit days and examine quitting self-efficacy, medication adherence, and other demographic and smoking variables as predictors of successful quit initiation.…”

“…Yet, all of the smoking cessation pharmacotherapies that have been tested in opioiddependent persons have far lower quit rates (Mooney et al, 2008;Okoli et al, 2010;Reid et al, 2008;Shoptaw et al, 2002;Stein et al, 2006) than those reported in trials of nondrug users (Hurt et al, 1994;Mooney et al, 2008;Okoli et al, 2010;Reid et al, 2008;Shoptaw et al, 2002;Stead et al, 2008;Stein et al, 2006). Over the last two decades, there have been four fully powered randomized clinical trials (RCTs) involving smoking cessation interventions specifically with MMT smokers (Haug, Advance Access publication June 20, 2014 nicotine & tobacco research, volume 16, number 11 (november 2014) 1463-1469 early quit days among methadone-maintained smokers Svikis, & Diclemente, 2004;Shoptaw et al, 2002;Stein et al, 2006Stein et al, , 2013Story & Stark, 1991).…”