Trials / Completed
CompletedNCT00937235
Treatment of Smoking Among Individuals With PTSD
Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 142 (actual)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Varenicline | 1 mg tablets, orally, twice daily x 12 weeks |
| BEHAVIORAL | Medication Management Counseling | 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation |
| BEHAVIORAL | Prolonged Exposure | 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2009-07-10
- Last updated
- 2017-11-14
- Results posted
- 2017-09-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00937235. Inclusion in this directory is not an endorsement.