A Phase 4 interventional study of Smoking Cessation Cognitive Behavioral Therapy (CBT) and Bupropion in Smoking and Stress Disorders, Post-Traumatic, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by VA Office of Research and Development · Phase 4, Interventional, and Treatment
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.
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.
268 studies on the registry are indexed under Smoking; 136 are open to participants now.
This study's enrollment of 115 is close to the median of 120 across 211 interventional studies indexed under Smoking.
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Exclusion Criteria:
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 (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
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
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
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
Monetary reinforcement for smoking abstinence that is bioverified by breath carbon monoxide and saliva samples.
Also known as: SMART
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
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.
Time frame: 6 month follow-up, up to 7 months from baseline
Number of Participants Whose Self-report of 30 Day Point Prevalence Abstinence From Smoking is Bioverified
30-day point prevalence abstinence is defined as no smoking in the prior 30 days.
Time frame: 6 month follow-up, up to 7 months from baseline
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.
Time frame: 4 month follow-up, up to 5 months from baseline
Number of Participants Whose Self-report of 30 Day Point Prevalence Abstinence From Smoking is Bioverified
30-day point prevalence abstinence is defined as no smoking in the prior 30 days.
Time frame: 4 month follow-up, up to 5 months from baseline
Number of Participants Who Self-report Prolonged Abstinence
Prolonged abstinence is defined as 30 days abstinent.
Time frame: 4 month follow-up, up to five months from baseline
Number of Participants Who Self-report Prolonged Abstinence
Prolonged abstinence is defined as 30 days abstinent.
Time frame: 6 month follow-up, up to 7 months from baseline
Number of Participants Who Self-report Early Abstinence
Early abstinence is defined as 2 consecutive sessions abstinent in first month of quit attempt.
Time frame: Measured at the post-treatment visit (2 weeks after treatment completed), up to 4.5 months from baseline
Number of Participants Who Attended Eight or More Sessions of Combined CPT and CBT for Smoking
Those who complete eight or more treatment sessions will be considered to have had an adequate treatment dose.
Time frame: Measured at the post-treatment visit (2 weeks after treatment completed), up to 4.5 months from baseline
Number of Sessions Attended by Participants
The average number of treatment sessions attended by participants in each group will be considered a measure of treatment engagement.
Time frame: Measured at the post-treatment visit (2 weeks after treatment completed), up to 4.5 months from baseline
| Milestone | CPT-SMART | Combined Contact Yoked Control |
|---|---|---|
| Started | 60 | 55 |
| Completed | 47 | 38 |
| Not completed | 13 | 17 |
| Withdrew: Lost to follow-up | 8 | 8 |
| Withdrew: Withdrawal by subject | 5 | 9 |
| Milestone | CPT-SMART | Combined Contact Yoked Control |
|---|---|---|
| Started | 47 | 38 |
| Completed | 41 | 30 |
| Not completed | 6 | 8 |
| Withdrew: Lost to follow-up | 3 | 4 |
| Withdrew: Withdrawal by subject | 3 | 4 |
| Milestone | CPT-SMART | Combined Contact Yoked Control |
|---|---|---|
| Started | 41 | 30 |
| Completed | 39 | 27 |
| Not completed | 2 | 3 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 |
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
| Participants | CPT-SMART | Combined Contact Yoked Control |
|---|---|---|
| Number of Participants Whose Self-report of 7 Day Point Prevalence Abstinence From Smoking is Bioverified | 16 | 15 |
30-day point prevalence abstinence is defined as no smoking in the prior 30 days.
| Participants | CPT-SMART | Combined Contact Yoked Control |
|---|---|---|
| Number of Participants Whose Self-report of 30 Day Point Prevalence Abstinence From Smoking is Bioverified | 12 | 14 |
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
| Participants | CPT-SMART | Combined Contact Yoked Control |
|---|---|---|
| Number of Participants Whose Self-report of 7 Day Point Prevalence Abstinence From Smoking is Bioverified | 18 | 16 |
30-day point prevalence abstinence is defined as no smoking in the prior 30 days.
| Participants | CPT-SMART | Combined Contact Yoked Control |
|---|---|---|
| Number of Participants Whose Self-report of 30 Day Point Prevalence Abstinence From Smoking is Bioverified | 14 | 13 |
Prolonged abstinence is defined as 30 days abstinent.
| Participants | CPT-SMART | Combined Contact Yoked Control |
|---|---|---|
| Number of Participants Who Self-report Prolonged Abstinence | 14 | 13 |
Prolonged abstinence is defined as 30 days abstinent.
| Participants | CPT-SMART | Combined Contact Yoked Control |
|---|---|---|
| Number of Participants Who Self-report Prolonged Abstinence | 12 | 12 |
Early abstinence is defined as 2 consecutive sessions abstinent in first month of quit attempt.
| Participants | CPT-SMART | Combined Contact Yoked Control |
|---|---|---|
| Number of Participants Who Self-report Early Abstinence | 25 | 22 |
Those who complete eight or more treatment sessions will be considered to have had an adequate treatment dose.
| Participants | CPT-SMART | Combined Contact Yoked Control |
|---|---|---|
| Number of Participants Who Attended Eight or More Sessions of Combined CPT and CBT for Smoking | 37 | 32 |
The average number of treatment sessions attended by participants in each group will be considered a measure of treatment engagement.
| sessions | CPT-SMART | Combined Contact Yoked Control |
|---|---|---|
| Number of Sessions Attended by Participants | 8.3 ± 4.7 | 7.8 ± 5.0 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CPT-SMART | 0/60 (0%) | 0/60 (0%) | 11/60 (18.3%) |
| Combined Contact Yoked Control | 0/55 (0%) | 0/55 (0%) | 16/55 (29.1%) |
| Event | CPT-SMART | Combined Contact Yoked Control |
|---|---|---|
| insomnia/nightmaresPsychiatric disorders | 2/60 | 8/55 |
| Bad taste in mouth/dry mouthGeneral disorders | 2/60 | 7/55 |
| increased mood or anxiety symptomsPsychiatric disorders | 5/60 | 4/55 |
| headacheGeneral disorders | 3/60 | 3/55 |
| dizzinessNervous system disorders | 3/60 | 0/55 |
| Age, Continuous(years) | CPT-SMART | Combined Contact Yoked Control | Total |
|---|---|---|---|
| Mean | 54.3 ± 11.30 | 52.55 ± 11.67 | 53.46 ± 11.46 |
| Sex: Female, Male(Participants) | CPT-SMART | Combined Contact Yoked Control | Total |
|---|---|---|---|
| Female | 13 | 15 | 28 |
| Male | 47 | 40 | 87 |
| Ethnicity (NIH/OMB)(Participants) | CPT-SMART | Combined Contact Yoked Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 3 | 3 |
| Not Hispanic or Latino | 59 | 51 | 110 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | CPT-SMART | Combined Contact Yoked Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 25 | 24 | 49 |
| White | 31 | 29 | 60 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(Participants) | CPT-SMART | Combined Contact Yoked Control | Total |
|---|---|---|---|
| United States | 60 | 55 | 115 |
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