Treatment of Smoking Among Individuals With PTSD
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Psychiatric, Tobacco Consumers |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 11/16/2017 |
| Start Date: | January 2009 |
| End Date: | December 2015 |
Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy
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.
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.
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);
- 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.
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
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