Treatment of Smoking Among Individuals With PTSD

University of Pennsylvania

Status and phase: Completed; Phase 2

Conditions: Cigarette Smoking; Tobacco Use Disorder; Post-traumatic Stress Disorder; Nicotine Dependence

Treatments: Drug: Varenicline; Behavioral: Medication Management Counseling; Behavioral: Prolonged Exposure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00937235

R01DA023507 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

Integrated Treatment

Experimental group

Description:

Prolonged Exposure + Varenicline + Medication Management Counseling

Treatment:

Behavioral: Prolonged Exposure

Behavioral: Medication Management Counseling

Drug: Varenicline

Varenicline

Active Comparator group

Description:

Varenicline + Medication Management Counseling

Treatment:

Behavioral: Medication Management Counseling

Drug: Varenicline