{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Rohsenow DJ"],"funding":["Intramural NIH HHS","NIDA NIH HHS","National Institute on Drug Abuse"],"pagination":["1808-1820"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12435192"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["112(10)"],"pubmed_abstract":["<h4>Aims</h4>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.<h4>Design</h4>Double-blind double-placebo-controlled randomized design, stratifying by MDD, gender and nicotine dependence, with 3 and 6 months follow-up.<h4>Setting</h4>University offices in Rhode Island, USA.<h4>Participants</h4>Adult smokers (n = 137), in SUD treatment, substance abstinent <12 months (n = 77 varenicline, 60 NRT).<h4>Intervention and comparator</h4>Twelve weeks of varenicline (2 mg/day, after 1-week dose run-up) or NRT (21 mg/day decreasing to 7 mg/day).<h4>Measurements</h4>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.<h4>Findings</h4>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.<h4>Conclusions</h4>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."],"journal":["Addiction (Abingdon, England)"],"pubmed_title":["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."],"pmcid":["PMC12435192"],"funding_grant_id":["R01 DA024652","1R01DA024652","Z99 DA999999"],"pubmed_authors":["Leggio L","Tidey JW","Rohsenow DJ","Colby SM","Monti PM","Martin RA","Swift RM"],"additional_accession":[]},"is_claimable":false,"name":"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.","description":"<h4>Aims</h4>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.<h4>Design</h4>Double-blind double-placebo-controlled randomized design, stratifying by MDD, gender and nicotine dependence, with 3 and 6 months follow-up.<h4>Setting</h4>University offices in Rhode Island, USA.<h4>Participants</h4>Adult smokers (n = 137), in SUD treatment, substance abstinent <12 months (n = 77 varenicline, 60 NRT).<h4>Intervention and comparator</h4>Twelve weeks of varenicline (2 mg/day, after 1-week dose run-up) or NRT (21 mg/day decreasing to 7 mg/day).<h4>Measurements</h4>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.<h4>Findings</h4>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.<h4>Conclusions</h4>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.","dates":{"release":"2017-01-01T00:00:00Z","publication":"2017 Oct","modification":"2026-06-01T06:21:10.993Z","creation":"2026-04-08T09:45:57.664Z"},"accession":"S-EPMC12435192","cross_references":{"pubmed":["28498504"],"doi":["10.1111/add.13861"]}}