CPT-SMART for Treatment of PTSD and Cigarette Smoking

NCT03978442 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: MHBB-008-18F
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stress Disorders, Post-Traumatic; Smoking

Outcome Measures

Primary Outcomes (1)

• Number of participants whose self-report of 7 day point prevalence abstinence from smoking is bioverified

  7-day point prevalence abstinence is defined as no smoking in the prior 7 days.

  6 month follow-up

Secondary Outcomes (8)

• Number of participants whose self-report of 30 day point prevalence abstinence from smoking is bioverified

  6 month follow-up

• Number of participants whose self-report of 7 day point prevalence abstinence from smoking is bioverified

  4 month follow-up

• Number of participants whose self-report of 30 day point prevalence abstinence from smoking is bioverified

  4 month follow-up

• Number of participants who self-report prolonged abstinence

  4 month follow-up

• Number of participants who self-report prolonged abstinence

  6 month follow-up

Study Arms (2)

CPT-SMART

EXPERIMENTAL

COGNITIVE PROCESSING THERAPY with SMOKING ABSTINENCE REINFORCEMENT THERAPY (CPT-SMART) - an intervention that combines evidence-based PTSD treatment with guideline-concordant cognitive-behavioral smoking cessation counseling, bupropion, and intensive behavioral therapy through CM.

Behavioral: Smoking Cessation Cognitive Behavioral Therapy (CBT); Drug: Bupropion; Behavioral: Cognitive Processing Therapy; Behavioral: Smoking Abstinence Reinforcement Therapy

Combined Contact Yoked Control

ACTIVE COMPARATOR

COMBINED CONTACT YOKED CONTROL (CCYC) - an intervention that is identical to CPT-SMART for PTSD and smoking treatment, except for using non-contingent payment (i.e., yoked CM) to control for compensation and monitoring.

Behavioral: Smoking Cessation Cognitive Behavioral Therapy (CBT); Drug: Bupropion; Behavioral: Cognitive Processing Therapy; Behavioral: Yoked Contingency Management

Interventions

Smoking Cessation Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

Also known as: CBT

CPT-SMART; Combined Contact Yoked Control

Bupropion DRUG

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.

Also known as: Zyban

CPT-SMART; Combined Contact Yoked Control

Cognitive Processing Therapy BEHAVIORAL

12 sessions of CPT, which is a well-established trauma-focused psychotherapy for PTSD that has demonstrated efficacy and effectiveness in Veterans.

Also known as: CPT

CPT-SMART; Combined Contact Yoked Control

Smoking Abstinence Reinforcement Therapy BEHAVIORAL

Monetary reinforcement for smoking abstinence that is bioverified by breath carbon monoxide and saliva samples.

Also known as: SMART

CPT-SMART

Yoked Contingency Management BEHAVIORAL

Participants in the yoked control will receive the monetary reinforcement of their yoked participant regardless of smoking abstinence or session attendance.

Also known as: Control CM

Combined Contact Yoked Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is Veteran
• Is between the ages of 18 and 80
• Smokes ten or more cigarettes per day for the past year
• Has been smoking for at least the past year
• Meets criteria for current PTSD
• Speaks and writes English
• Is willing to attempt smoking cessation and trauma-focused psychotherapy

You may not qualify if:

• Has had myocardial infarction in the past 6 months
• Uses other forms of nicotine that he/she is unwilling to stop
• Is pregnant
• Has a primary psychotic disorder
• Has a current substance use disorder other than tobacco use disorder
• Has a contraindication to bupropion use with no medical clearance to use it
• Is unwilling to use bupropion
• Is receiving other behavioral smoking counseling or trauma-focused therapy or plans to do so during the study period
• Is currently imprisoned or in psychiatric hospitalization

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Smoking; Stress Disorders, Post-Traumatic

Interventions

Bupropion; 2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Eric A Dedert, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized, two-arm clinical trial

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 7, 2019
• Study Start: November 7, 2019
• Primary Completion: October 8, 2025
• Study Completion: October 8, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)