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Longitudinal Findings from a Randomized Clinical Trial of Varenicline for Alcohol Use Disorder with Comorbid Cigarette Smoking
Author(s) -
Bold Krysten W.,
Zweben Allen,
Fucito Lisa M.,
Piepmeier Mary E.,
Muvvala Srinivas,
Wu Ran,
Gueorguieva Ralitza,
O'Malley Stephanie S.
Publication year - 2019
Publication title -
alcoholism: clinical and experimental research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.267
H-Index - 153
eISSN - 1530-0277
pISSN - 0145-6008
DOI - 10.1111/acer.13994
Subject(s) - varenicline , placebo , medicine , smoking cessation , abstinence , alcohol use disorder , randomized controlled trial , nicotine , anesthesia , alcohol , psychiatry , biochemistry , chemistry , alternative medicine , pathology
Background This study is the first to examine longitudinal posttreatment outcomes of a placebo‐controlled trial of varenicline for alcohol use disorder (AUD) with comorbid cigarette smoking. Methods Participants were 131 adults ( n = 39 female) seeking alcohol treatment in a randomized, double‐blind, parallel group, placebo‐controlled, 16‐week multisite trial of varenicline combined with medical management (MM). Timeline follow‐back assessments of alcohol and smoking behavior were conducted at the end of treatment (4 months), with follow‐ups at 6, 9, and 12 months. Outcomes were percentage of heavy drinking days (PHDD), percent of participants with no heavy drinking days (NHDD), cotinine‐confirmed prolonged smoking abstinence (PA), and good clinical outcome on either NHDD or PA. Results Treatment improvements were maintained posttreatment. For the sample overall, PHDD or NHDD did not differ significantly by treatment condition ( p s > 0.13), but varenicline produced higher rates of PA versus placebo at 4, 9, and 12 months ( p < 0.05). Significant differences were observed by sex: Males had higher rates of NHDD with varenicline (28.9%) versus placebo (6.4%) at the end of treatment ( p = 0.004), and these effects were maintained at 12 months (varenicline: 40.0% vs. placebo: 19.2%, p = 0.03). Higher rates of PA were seen for varenicline in both males (8.9%) and females (21.1%) versus placebo (males/females: 0%) at the end of treatment ( p = 0.05), and this effect was maintained at 12 months for females (varenicline: 21.1% vs. placebo, 0.0%, p = 0.05). Conclusions Varenicline treatment combined with MM appears to have enduring benefits for patients with co‐occurring AUD and cigarette smoking, and these effects may differ by sex.