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

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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.


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.
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