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Treatment of Smoking Among Individuals With PTSD

NCT00937235 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2017-11-14

Study results available
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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

  • Cigarette Smoking
  • Nicotine Dependence
  • Post-traumatic Stress Disorder
  • Tobacco Use Disorder

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Edna B Foa, Ph.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00937235 on ClinicalTrials.gov