At a glance
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Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy
In Brief
A Phase 2 clinical trial evaluating Varenicline, Medication Management Counseling, and 1 other intervention for Cigarette Smoking and 3 related conditions. Completed, enrolled 142 participants across 1 site.
Detailed Summary
This study will examine the effect of combining prolonged exposure, a cognitive-behavioral treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the end of treatment and 6-month follow-up. We hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease in cigarettes smoked will be greater among participants who receive the combined treatment for both PTSD and smoking.
Study Details
Timeline
Interventions
1 mg tablets, orally, twice daily x 12 weeks
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders