Treatment of Smoking Among Individuals With PTSD

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy

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

Intervention / Treatment
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* Drug: Varenicline
* Behavioral: Medication Management Counseling
* Behavioral: Prolonged Exposure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Treatment<br>Prolonged Exposure + Varenicline + Medication Management Counseling | Drug: Varenicline<br>* 1 mg tablets, orally, twice daily x 12 weeks<br>* Other names: Chantix;Behavioral: Medication Management Counseling<br>* 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation<br>Behavioral: Prolonged Exposure<br>* 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders<br>* Other names: Cognitive-Behavioral Therapy;|
| Active Comparator: Varenicline<br>Varenicline + Medication Management Counseling | Drug: Varenicline<br>* 1 mg tablets, orally, twice daily x 12 weeks<br>* Other names: Chantix;Behavioral: Medication Management Counseling<br>* 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With 7-day Point Prevalence Smoking Abstinence | Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of <15ng/ml, and CO < 10 ppm. | At 3-month follow-up (6-month post-quit day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Serum Cotinine | Level of cotinine in blood | At end of 3-month follow-up | 
| Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment | Posttraumatic Symptom Scale Interview at post-treatment assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51. Higher scores indicate higher/worse levels of PTSD. | Post-treatment, occurring 12 weeks after the start of treatment (week 0) | 
| Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up | Posttraumatic Symptom Scale Interview at 3-month follow-up assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51. Higher scores indicate higher/worse levels of PTSD. | 3-month follow-up | 
| Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment | Hamilton Depression scale (HAM-D) at post-treatment assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50. Higher scores indicate higher/worse levels of depression. | Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0) | 
| Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up | Hamilton Depression scale (HAM-D) at 3-month followup assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50. Higher scores indicate higher/worse levels of depression. | 3-month follow-up | 
| TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment) | Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit | Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit | 
| TLFB - Cigarettes Smoked Week Before 3-Month Follow-up | Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit | 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Anxiety, Behavior Therapy, Varenicline