CPT-SMART for Treatment of PTSD and Cigarette Smoking

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.

Conditions

• Smoking
• Stress Disorders, Post-Traumatic

Interventions

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.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Eric A Dedert, PhD · Durham VA Medical Center, Durham, NC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-07

Primary Completion

2025-10-08

Completion

2025-10-08

FDA Drug

Yes

Countries

• United States

Study Locations