Treatment of Smoking Among Individuals With PTSD
Condition: Cigarette Smoking; Nicotine Dependence; Post-traumatic Stress Disorder; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Varenicline; Medication Management Counseling; Prolonged Exposure
Intervention description: 1 mg tablets, orally, twice daily x 12 weeks; 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation; 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Smoking Cessation; Anxiety; Behavior Therapy; Varenicline

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.
    

Eligibility criteria:

        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.