NCT03978442

CPT-SMART for Treatment of PTSD and Cigarette Smoking

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Smoking is the leading cause of preventable illness, disability, and death in the United States. The rate of smoking is disproportionately higher among Veterans with posttraumatic stress disorder (PTSD). Unfortunately, smoking cessation efforts that are effective in the general population have shown limited effectiveness in smokers with PTSD. The high smoking rate and difficulty with achieving abstinence indicate a critical need to develop effective interventions for Veterans who smoke and have PTSD. The investigators' data indicate that negative emotions and trauma reminders are associated with relapse for smokers with PTSD. In this context, an ideal strategy may be to combine evidence-based PTSD treatment with intensive smoking cessation treatment to maximize quit rates. Cognitive processing therapy (CPT) is a well-established evidence-based treatment for PTSD. The investigators have successfully developed a treatment manual that combines CPT with cognitive-behavioral counseling for smoking cessation. Contingency management (CM) is another intensive behavioral treatment that has been shown to help with reducing smoking. CM provides positive reinforcers such as money to individuals misusing substances contingent upon abstinence from use. The primary goal of this study is to evaluate the efficacy of a treatment that combines CM with cognitive-behavioral smoking cessation counseling, smoking cessation medication, and CPT. Proposed is a randomized, two-arm clinical trial in which 120 Veteran smokers with PTSD will be randomized to either: 1) COGNITIVE PROCESSING THERAPY with SMOKING ABSTINENCE REINFORCEMENT THERAPY (CPT-SMART) or 2) COMBINED CONTACT CONTROL, an intervention identical to CPT-SMART in PTSD and smoking treatment, except for using payment that is not contingent on abstinence. Specific aims include: AIM 1) To evaluate the efficacy of CPT-SMART on rates of short- and long-term abstinence from cigarettes; AIM 2) To evaluate the impact of CPT-SMART on treatment engagement and utilization; and an EXPLORATORY AIM) To explore mechanisms of CPT-SMART on long-term smoking abstinence. The positive public health impact of reducing smoking among Veterans with PTSD could be enormous as it would prevent significant smoking-related morbidity and mortality.

Detailed description

Smoking is the leading cause of preventable illness, disability, and death in the United States. The rate of smoking is disproportionately higher among Veterans with posttraumatic stress disorder (PTSD). Unfortunately, smoking cessation efforts that are effective in the general population have shown limited effectiveness in smokers with PTSD. The high smoking rate and difficulty with achieving abstinence indicate a critical need to develop effective interventions for PTSD smokers. The investigators' data indicate that negative affect and trauma reminders are a significant antecedent of relapse for PTSD smokers. Further, despite evidence that nicotine may exacerbate PTSD symptoms, many smokers with PTSD expect that smoking helps manage their symptoms. In this context, an ideal strategy may be to combine evidence-based PTSD treatment with intensive smoking cessation treatment to maximize quit rates in this at-risk population. Cognitive processing therapy (CPT) is a well-established evidence-based treatment for PTSD. The investigators have successfully developed a treatment manual that integrates CPT with guideline-concordant cognitive-behavioral counseling for smoking cessation. Contingency management (CM) is an intensive behavioral treatment that has demonstrated efficacy for reducing smoking in a range of difficult-to-treat populations, including individuals with psychiatric disorders. CM provides positive reinforcers (e.g., vouchers, money) to individuals misusing substances contingent upon bioverified abstinence from drug use. The primary goal of the current study is to evaluate the efficacy of an intervention that combines clinic-based CM using twice weekly monitoring with salivary cotinine test strips, cognitive-behavioral smoking cessation counseling, smoking cessation medication, and evidence-based PTSD treatment. Proposed is a randomized, two-arm clinical trial in which 120 Veteran smokers with PTSD will be randomized to either: 1) COGNITIVE PROCESSING THERAPY with SMOKING ABSTINENCE REINFORCEMENT THERAPY (CPT-SMART) - an intervention that combines evidenced-based PTSD treatment with guideline-concordant cognitive-behavioral smoking cessation counseling, bupropion, and intensive behavioral therapy through CM; or 2) COMBINED CONTACT CONTROL: an intervention identical to CPT-SMART in PTSD and smoking treatment, except for using non-contingent payment (i.e., yoked CM) to control for compensation and monitoring. Specific aims include: AIM 1) To evaluate the efficacy of CPT-SMART on rates of short- and long-term abstinence from cigarettes (assessed with multiple measures including bioverified abstinence) measured at 1-week post-treatment, 4-months, and 6 months; AIM 2) To evaluate the impact of CPT-SMART on treatment engagement and utilization; and an EXPLORATORY AIM) To explore mechanisms of CPT-SMART on long-term smoking abstinence, including self-efficacy, salience of smoking, and psychiatric symptom reduction. The VA has already implemented CM for treatment of substance abuse. If shown efficacious, a combined PTSD treatment plus incentive-based approaches for smoking could be implemented into specialty PTSD programs. The positive public health impact of reducing smoking among Veterans with PTSD could be enormous as it would prevent significant smoking-related morbidity and mortality.

Conditions

• Smoking
• Stress Disorders, Post-Traumatic

Interventions

Type	Name	Description
BEHAVIORAL	Smoking Cessation Cognitive Behavioral Therapy (CBT)	12 sessions of cognitive behavioral therapy for smoking cessation, designed to help participants prepare for quitting smoking, make a quit attempt, and stay quit from smoking.
DRUG	Bupropion	All medically eligible participants will be prescribed bupropion to begin 7 days before the quit date and continued through 12 weeks post-quit. Participants will be scheduled to begin at 150mg/day of bupropion for at least 3 days before titrating up to 300mg/day dose of bupropion.
BEHAVIORAL	Cognitive Processing Therapy	12 sessions of CPT, which is a well-established trauma-focused psychotherapy for PTSD that has demonstrated efficacy and effectiveness in Veterans.
BEHAVIORAL	Smoking Abstinence Reinforcement Therapy	Monetary reinforcement for smoking abstinence that is bioverified by breath carbon monoxide and saliva samples.
BEHAVIORAL	Yoked Contingency Management	Participants in the yoked control will receive the monetary reinforcement of their yoked participant regardless of smoking abstinence or session attendance.

Timeline

• Start date: 2019-11-07
• Primary completion: 2025-10-08
• Completion: 2025-10-08
• First posted: 2019-06-07
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study