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NCT00937235 · ClinicalTrials.gov registry record · Phase 2
Treatment of Smoking Among Individuals With PTSD
A Phase 2 study of Post Traumatic Stress Disorder and Tobacco Use Disorder, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
- 1
- Study location
NCT00937235: Completed Phase 2 study of Post Traumatic Stress Disorder and Tobacco Use Disorder, sponsored by University of Pennsylvania.
NCT00937235 is a Phase 2 study of Post Traumatic Stress Disorder and Tobacco Use Disorder that has completed, run by University of Pennsylvania. The registered enrollment target is 142 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00937235, a Phase 2 study of Post Traumatic Stress Disorder and Tobacco Use Disorder, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of \<15ng/ml, and CO \< 10 ppm.
Conditions Studied
Interventions
- DRUG Varenicline
- BEHAVIORAL Prolonged Exposure
- BEHAVIORAL Medication Management Counseling
Study Locations (1)
Pennsylvania
- University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2009-01 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT00937235 record still lists
NCT00937235 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (79% lower).
The record links to 4 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 3 interventions - of which Varenicline is the first listed.
NCT00937235 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00937235 about?
NCT00937235 is a clinical study titled "Treatment of Smoking Among Individuals With PTSD". 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...
What is the current status of trial NCT00937235?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2009-01. Estimated completion is 2015-12.
What conditions does trial NCT00937235 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Tobacco Use Disorder, Nicotine Dependence, Cigarette Smoking.
What interventions are being tested in trial NCT00937235?
The interventions under investigation include: Varenicline (DRUG), Prolonged Exposure (BEHAVIORAL), Medication Management Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT00937235?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00937235 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00937235's enrollment target sits among peer trials
142 83rd of 262 higher than 180 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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