Phase 2
Completed N=142
Treatment of Smoking Among Individuals With PTSD
Cigarette Smoking · Nicotine Dependence · Post-Traumatic Stress Disorder · Tobacco Use
Source: ClinicalTrials.gov NCT00937235 ↗
Enrolled (actual)
142
Serious AEs
7.0%
Results posted
Sep 2017
Primary outcomePrimary: Number of Participants With 7-day Point Prevalence Smoking Abstinence — 8; 11 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 7-day Point Prevalence Smoking Abstinence |
8; 11 | — |
| SECONDARY Blood Serum Cotinine |
156.0; 149.2 | — |
| SECONDARY Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment |
11.19; 18.84 | — |
| SECONDARY Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up |
10.35; 16.74 | — |
| SECONDARY Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment |
6.34; 11.84 | — |
| SECONDARY Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up |
6.95; 11.45 | — |
| SECONDARY TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment) |
14.31; 17.03 | — |
| SECONDARY TLFB - Cigarettes Smoked Week Before 3-Month Follow-up |
32.92; 25.85 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00937235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.