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SmokingPhase 4CPT-SMARTNCT03978442

CPT-SMART for Treatment of PTSD and Cigarette Smoking

A Phase 4 study testing Smoking Cessation Cognitive Behavioral Therapy (CBT), Bupropion and Cognitive Processing Therapy in people with Smoking and Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Smoking, Stress Disorders, Post-Traumatic
What is being tested?
Smoking Cessation Cognitive Behavioral Therapy (CBT), Bupropion and Cognitive Processing Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
1 siteUnited States
Study dates
7 Nov 2019to 8 Oct 2025
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875

Other trials in United States

About this study

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.

Read the 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.

Being tested
Smoking Cessation Cognitive Behavioral Therapy (CBT), Bupropion, Cognitive Processing Therapy, Smoking Abstinence Reinforcement Therapy, Yoked Contingency Management
Keywords
Stress Disorders, Post-Traumatic, Smoking
Medical subject headings
Smoking, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smoking Cessation Cognitive Behavioral Therapy (CBT)Behavioural

    Also called 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.

  • BupropionDrug

    Also called Zyban

    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.

  • Cognitive Processing TherapyBehavioural

    Also called CPT

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

  • Smoking Abstinence Reinforcement TherapyBehavioural

    Also called SMART

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

  • Yoked Contingency ManagementBehavioural

    Also called Control CM

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

Study groups in NCT03978442
Study groupRoleWhat they receive
CPT-SMARTExperimentalCOGNITIVE 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.
Receives: Behavioral: Smoking Cessation Cognitive Behavioral Therapy (CBT); Drug: Bupropion; Behavioral: Cognitive Processing Therapy; Behavioral: Smoking Abstinence Reinforcement Therapy
Combined Contact Yoked ControlActive comparatorCOMBINED 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.
Receives: Behavioral: Smoking Cessation Cognitive Behavioral Therapy (CBT); Drug: Bupropion; Behavioral: Cognitive Processing Therapy; Behavioral: Yoked Contingency Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 month follow-up, up to 7 months from baseline

Secondary outcomes (8)
  1. 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.

    Measured: 6 month follow-up, up to 7 months from baseline

  2. 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.

    Measured: 4 month follow-up, up to 5 months from baseline

  3. 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.

    Measured: 4 month follow-up, up to 5 months from baseline

  4. Number of Participants Who Self-report Prolonged Abstinence

    Prolonged abstinence is defined as 30 days abstinent.

    Measured: 4 month follow-up, up to five months from baseline

  5. Number of Participants Who Self-report Prolonged Abstinence

    Prolonged abstinence is defined as 30 days abstinent.

    Measured: 6 month follow-up, up to 7 months from baseline

  6. Number of Participants Who Self-report Early Abstinence

    Early abstinence is defined as 2 consecutive sessions abstinent in first month of quit attempt.

    Measured: Measured at the post-treatment visit (2 weeks after treatment completed), up to 4.5 months from baseline

  7. 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.

    Measured: Measured at the post-treatment visit (2 weeks after treatment completed), up to 4.5 months from baseline

  8. 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.

    Measured: Measured at the post-treatment visit (2 weeks after treatment completed), up to 4.5 months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2019
  2. Study start7 Nov 2019
  3. Primary completion8 Oct 2025
  4. Study completion8 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, two-arm clinical trial
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03978442
Sponsor's protocol ID
MHBB-008-18F
Acronym
CPT-SMART
Status last verified
Jun 2026
First submitted
5 Jun 2019
Last updated
2 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: We do not plan to attend individual participant data.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Smoking Cessation Cognitive Behavioral Therapy (CBT), Bupropion and Cognitive Processing Therapy in people with Smoking and Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Whose Self-report of 7 Day Point Prevalence Abstinence From Smoking is Bioverified (time frame: 6 month follow-up, up to 7 months from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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