View Clinical Trial (Medical Research Study)
Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy
| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19104 |
| Conditions: |
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Cigarette Smoking - Nicotine Dependence - Post-traumatic Stress Disorder - Tobacco Use Disorder |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Male or female treatment-seeking cigarette smokers between 18-75 years old who smoke
an average of ≥10 cigarettes/day during past year;
- Current diagnosis of chronic PTSD (symptom duration > 3 months) with clinically
significant trauma-related symptoms (PSS-I >= 20)
- Live a commutable distance to the University of Pennsylvania and agree to follow-up
visits;
- Agree not to use other forms of smoking cessation treatment or treatment for PTSD
during the study period;
- If taking SRIs or other medications at intake, have been on stable medication and
dose regimen for past 3 months and agree to maintain current regimen if possible;
- Demonstrate the capacity to provide informed consent;
- Speak and read English.
Exclusion Criteria:
- History of drug or alcohol abuse or dependence in past 3 months or any unwillingness
to not smoke marijuana during the first 13 weeks of the study;
- Current and continuing intimate relationship with a physically or sexually abusive
partner;
- Current suicidal ideation with intent and/or plan that, in the judgment of the
investigator, should be the focus of treatment;
- Prior serious suicide attempt, as judged by the evaluator to have a high degree of
lethality;
- Current or past history of psychosis (bipolar disorder or schizophrenia);
- Significant cardiovascular disease or uncontrolled hypertension in past 6 months;
- Women who are pregnant, likely to become pregnant (i.e., sexually active and not
using contraception), or nursing.
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| NCT ID: |
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NCT00937235 |
| Primary Contact: |
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Principal Investigator
Edna B Foa, Ph.D.
University of Pennsylvania
Edna B Foa, Ph.D.
Phone: 215-746-3327
Email: foa@mail.med.upenn.edu
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| Backup Contact: |
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Email: gillihan@mail.med.upenn.edu
Seth J Gillihan, Ph.D.
Phone: 215-746-3327
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| Location Contact: |
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Philadelphia, Pennsylvania 19104
United States
Edna B Foa, Ph.D.
Phone: 215-746-3327
Email: foa@mail.med.upenn.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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