clinicaltrials.gov Identifier: NCT01553136.

Background: This study is the first to examine longitudinal post-treatment outcomes of a placebo-controlled trial of varenicline for alcohol use disorder 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 multi-site trial of varenicline combined with medical management (O'Malley et al., 2018). 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 (GCO) on either NHDD or PA. Results: Treatment improvements were maintained post-treatment. For the sample overall, PHDD or NHDD did not differ significantly by treatment condition (ps>.13), but varenicline produced higher rates of PA vs. placebo at 4, 9, and 12 months (p<.05). Significant differences were observed by sex: Males had higher rates of NHDD with varenicline (28.8%) vs. placebo (6.4%) at the end of treatment (p=.004), and these effects were maintained at 12 months

Background Medication nonadherence is a ubiquitous problem in pharmacology treatment for alcohol use disorders. Unintentional and purposeful nonadherence as measured by the Medication Adherence Questionnaire (MAQ) has been shown to predict problems with medication adherence; however, feedback from the MAQ has never been incorporated into a behavioral intervention to facilitate medication adherence. We assessed the integration of the MAQ into Medical Management (MM), a counseling approach frequently employed in conjunction with alcohol pharmacotherapy, to determine whether prior patterns of nonadherence could be addressed effectively to promote medication adherence. Methods We conducted a post-hoc analysis of data from 131 alcohol dependent smokers who participated in a double blind, placebo controlled study of varenicline for the treatment of alcohol dependence. At baseline, participants completed a single administration of the MAQ, which asks 2 questions about unintentional nonadherence (e.g., forgetting) and 2 questions about purposeful nonadherence (e.g., stopping because feeling good or feeling bad). Based on these responses, participants were divided into 1 of 3 three categories. Adherent (n=60), Unintentional or Purposeful Nonadherent (n=50) and Unintentional and Purposeful Nonadherent (n=21). Over the course of the 16-week treatment period, patients were expected to participate in 12 Medical Management (MM) sessions; a brief psychosocial treatment. Feedback based on the MAQ responses was integrated into the MM sessions to facilitate medication and treatment adherence. Results The 3 adherence groups were compared on baseline characteristics, medication adherence, treatment attendance and end-of-treatment patient ratings of treatment helpfulness. Baseline demographics and characteristics were not significantly different among the three categories. We found no statistically significant differences among the three groups with respect to pill adherence, treatment attendance, and treatment satisfaction ratings. Conclusions The findings suggest that the incorporation of MAQ feedback into the MM approach could be effective in mitigating risks associated with prior patterns of nonadherence suggesting that further testing of the integrated behavioral approach is warranted.

It is now widely recognized that brief intervention can be an effective approach in addressing substance use problems in nonspecialty settings where universal screenings are conducted for risky or hazardous drinking,