Status:
COMPLETED
Treatment of Smoking Among Individuals With PTSD
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cigarette Smoking
Nicotine Dependence
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 trea...
Eligibility Criteria
Inclusion
- 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
- 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);
- History of 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00937235
Start Date
January 1 2009
End Date
December 1 2015
Last Update
November 14 2017
Active Locations (1)
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1
University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety
Philadelphia, Pennsylvania, United States, 19104