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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 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 1,116-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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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.

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

FieldValue
Enrollment Target 142 participants
Start Date 2009-01
Est. Completion 2015-12
Phase Phase 2

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT00937235

The ClinicalTrials.gov registry entry for NCT00937235 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,116-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (87% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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