Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers
Overview
- Phase
- Phase 4
- Intervention
- Standard treatment
- Conditions
- Nicotine Dependence
- Sponsor
- Northwestern University
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Bioverified Point-prevalence Abstinence at 27 Weeks
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Persons who struggle with depression smoke at high rates and experience low quit rates in treatment. The best way to improve cessation treatment for this underserved population remains unknown. The proposed trial tests whether the combination of varenicline and behavioral mood management treatment enhances long-term abstinence for depressed smokers and, if so, whether this treatment achieves its effects through addressing the unique psychological factors that appear to maintain tobacco dependence for these smokers.
Detailed Description
Upwards of 43% of persons with major depressive disorder (MDD) are daily smokers who are more likely to smoke heavily, show greater tobacco dependence, suffer more severe withdrawal, and experience lower quit rates than smokers without MDD. Little is known about treatment strategies that might optimize smoking cessation for smokers with MDD because almost all randomized clinical trials have excluded these smokers. This project answers many prominent but largely unanswered calls over the last decade to address tobacco dependence in persons with mental health disorders, especially major depressive disorder (MDD). Using a double-blind, placebo-controlled, randomized design, the investigators will evaluate the efficacy of behavioral activation for smoking cessation (BASC) plus varenicline for treating tobacco dependence in smokers with current or lifetime MDD. Three hundred and thirty daily (≥1 cigarettes/day) smokers will be randomized to receive 12 weeks of one of four treatments: 1) Standard behavioral cessation treatment (ST) + placebo; 2) Behavioral activation integrated with ST (BASC) + placebo; 3) ST + varenicline; or 4) BASC + varenicline. Both BASC and ST will be administered in eight 45 minute sessions, occurring weekly for the first four weeks and biweekly for the final eight weeks. Randomization will be stratified on clinical site (Northwestern, University of Pennsylvania), gender, and severity of depressive symptoms (minimal/mild vs. moderate/severe). The primary outcomes will be carbon monoxide (CO) verified 7-day point prevalence abstinence at 24-weeks post-quit. Additional aims include assessing adverse event rates between varenicline and placebo arms, and testing for mediation of treatment effects by anhedonia, cognitive function (attention and memory), cigarette reward value, and craving and withdrawal. This randomized controlled trial will be the first adequately powered trial of BASC in this population; the first trial to evaluate varenicline among a community sample of smokers with MDD; and the first trial to assess the main and combined effects of these two treatments.
Investigators
Brian Hitsman
Associate Professor of Preventive Medicine
Northwestern University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Standard treatment + placebo varenicline
Standard behavioral smoking cessation treatment plus placebo varenicline
Intervention: Standard treatment
BASC + placebo varenicline
Behavioral activation for smoking cessation plus placebo varenicline
Intervention: BASC
Standard treatment + active varenicline
Standard behavioral smoking cessation treatment plus active varenicline
Intervention: Varenicline
Standard treatment + active varenicline
Standard behavioral smoking cessation treatment plus active varenicline
Intervention: Standard treatment
BASC + active varenicline
Behavioral activation for smoking cessation plus active varenicline
Intervention: Varenicline
BASC + active varenicline
Behavioral activation for smoking cessation plus active varenicline
Intervention: BASC
Outcomes
Primary Outcomes
Bioverified Point-prevalence Abstinence at 27 Weeks
Time Frame: 27 weeks (24-weeks post-target quit date)
Participants were classified as abstinent if they reported abstinence, not even a puff of a cigarette, for \>7 days prior to week 27 (24 weeks post-target quit date) and had an expired carbon monoxide reading of ≤ 6 parts per million at week 27.
Adverse Event and Serious Adverse Event Rates
Time Frame: Weeks 1 (1-week before starting medication), 6, and 14 (end of medication)
Adverse event and serious adverse event rates between varenicline and placebo arms. A previously developed algorithm was used to classify side effect reports as adverse events (AEs) or serious adverse events (SAEs) (Schnoll et al. 2019). Reference: Schnoll, R., Leone, F., Weisbrot, J., Veluz-Wilkins, A., Miele, A., Hole, A., Jao, N.C., Wileyto, E.P., Carroll, A.J., Kalhan, R., Patel, J., Langer, C., \& Hitsman, B. (2019). A randomized controlled trial of 24-weeks of varenicline for tobacco use among cancer patients: Efficacy, safety, and adherence. Psycho-Oncology, 28, 561-569.
Secondary Outcomes
- Time to 7-day Relapse(27 weeks (24 weeks post target quit date))
- Prolonged Abstinence(27 weeks (24 weeks post target quit date))
- Bioverified Point-prevalence Abstinence at 14 Weeks (End of Treatment)(14 weeks (11-weeks post-target quit date))
- Continuous Abstinence(27 weeks (24 weeks post target quit date))