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Varenicline versus nicotine patch with brief advice for smokers with substance use disorders with or without depression: effects on smoking, substance use and depressive symptoms
Aims
Varenicline was compared with transdermal nicotine (NRT) for smokers with current substance use disorders (SUD) for effects on 3‐month smoking abstinence (primary outcome) and, secondarily, on 3‐ and 6 month abstinence while adjusting for medication adherence, and on additional smoking and substance use outcomes. Moderation by major depressive disorder history (MDD) and adherence were investigated.
Design
Double‐blind double‐placebo‐controlled randomized design, stratifying by MDD, gender and nicotine dependence, with 3 and 6 months follow‐up.
Setting
University offices in Rhode Island, USA.
Participants
Adult smokers (n = 137), in SUD treatment, substance abstinent <12 months (n = 77 varenicline, 60 NRT).
Intervention and comparator
Twelve weeks of varenicline (2 mg/day, after 1‐week dose run‐up) or NRT (21 mg/day decreasing to 7 mg/day).
Measurements
Primary: point‐prevalence smoking abstinence (7‐day, confirmed) at 3 months. Secondary: point‐prevalence abstinence at 6 months, quantity and frequency of smoking and substance use at 3 and 6 months, and within‐treatment abstinence, medication adherence and depressive symptoms. Smoking outcome analyses were repeated controlling for adherence and investigating adherence as a moderator.
Findings
Effects on 3‐month abstinence were P < 0.065 without a covariate (Bayes factor 3.35, supporting the effect strongly) and differed significantly when controlling for baseline smoking [varenicline: 13%, NRT: 3%; odds ratio (OR) = 4.81, 95% confidence interval (CI) 1.00, 23.13, P < 0.05]. The threefold difference at 6 months was not significant. Medication effect on abstinence across time was significant (P < 0.05) covarying adherence and baseline smoking (OR = 6.40, 95% CI = 1.00, 40.93). Medication differences in 3‐month abstinence occurred among participants with ≥ 77% adherence (P < 0.02). No significant medication effects on heavy drinking, drug use or depressive symptoms were found.
Conclusions
Varenicline appears to improve the chances of achieving at least 3 months of smoking abstinence in smokers with substance use disorders trying to stop, compared with transdermal nicotine patches, the effect being independent of history of depressive disorder.