Conditions: Cigarette Smoking Nicotine Dependence Post-traumatic Stress Disorder Tobacco Use Disorder
Keywords: Smoking Cessation Anxiety Behavior Therapy Varenicline
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 142
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Prolonged Exposure + Varenicline + Medication Management Counseling arm 2: Varenicline + Medication Management Counseling

Interventions: intervention 1: Varenicline intervention 2: Medication Management Counseling intervention 3: Prolonged Exposure
Intervention descriptions: intervention 1: 1 mg tablets, orally, twice daily x 12 weeks intervention 2: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation intervention 3: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders

Protocol document: