Treatment of Smoking Among Individuals With PTSD

Phase 2

Completed

• Conditions: Cigarette Smoking; Nicotine Dependence; Post-traumatic Stress Disorder; Tobacco Use Disorder
• Interventions: Drug: Varenicline; Behavioral: Medication Management Counseling; Behavioral: Prolonged Exposure

• Registration Number: NCT00937235
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2017-03-28
• Results First Submitted QC: 2017-08-07
• Results First Posted: 2017-09-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated Treatment	Medication Management Counseling	Prolonged Exposure + Varenicline + Medication Management Counseling
Integrated Treatment	Prolonged Exposure	Prolonged Exposure + Varenicline + Medication Management Counseling
Varenicline	Medication Management Counseling	Varenicline + Medication Management Counseling
Integrated Treatment	Varenicline	Prolonged Exposure + Varenicline + Medication Management Counseling
Varenicline	Varenicline	Varenicline + Medication Management Counseling

Primary Outcome Measures

Name	Time	Method
Number of Participants With 7-day Point Prevalence Smoking Abstinence	At 3-month follow-up (6-month post-quit day)	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.

Secondary Outcome Measures

Name	Time	Method
Blood Serum Cotinine	At end of 3-month follow-up	Level of cotinine in blood
TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)	Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit	Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit
Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up	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.
Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment	Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)	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.
Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up	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.
TLFB - Cigarettes Smoked Week Before 3-Month Follow-up	3-month follow-up	Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit
Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment	Post-treatment, occurring 12 weeks after the start of treatment (week 0)	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.

Trial Locations

Locations (1)

University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety; 🇺🇸 Philadelphia, Pennsylvania, United States