Treatment of Smoking Among Individuals With PTSD

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder; Nicotine Dependence; Post-traumatic Stress Disorder; Cigarette Smoking
• Intervention / Treatment: Behavioral: Prolonged Exposure; Drug: Varenicline; Behavioral: Medication Management Counseling

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

Helpful Links

• Center for the Treatment and Study of Anxiety

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: July 8, 2009
• First Posted (Estimate): July 10, 2009

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Anxiety; Smoking Cessation; Varenicline; Behavior Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: R01DA023507 (U.S. NIH Grant/Contract)