Treatment of Smoking Among Individuals With PTSD

Official Title: “Treatment of Smoking Among Individuals With PTSD”

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.

Intervention(s) in this Clinical Trial

• Drug: Varenicline
  • 1 mg tablets, orally, twice daily x 12 weeks
• Behavioral: Medication Management Counseling
  • 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
• Behavioral: Prolonged Exposure
  • 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Integrated Treatment
  • Prolonged Exposure + Varenicline + Medication Management Counseling
• Active Comparator: Varenicline
  • Varenicline + Medication Management Counseling

Primary Measures

• 7-day point prevalence smoking abstinence
  • Time Frame: End of treatment and 6-month follow-up
    Safety Issue?: No

Secondary Measures

• Prolonged smoking abstinence
  • Time Frame: End of treatment and 6-month follow-up
    Safety Issue?: No
• Continuous smoking abstinence
  • Time Frame: End of treatment and 6-month follow-up
    Safety Issue?: No
• Days to smoking relapse
  • Time Frame: End of treatment and 6-month follow-up
    Safety Issue?: No
• Decrease in number of cigarettes smoked/day
  • Time Frame: End of treatment and 6-month follow-up
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National Institute on Drug Abuse (NIDA) NIH

Overall Clinical Trial Officials and Contacts

Edna B Foa, Ph.D. Principal Investigator University of Pennsylvania  

Overall Contact: Edna B Foa, Ph.D. 215-746-3327 foa@mail.med.upenn.edu

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00937235

Study ID Number: R01DA023507

ClinicalTrials.gov Identifier: NCT00937235

Health Authority: United States: Food and Drug Administration

Center for the Treatment and Study of Anxiety