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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Smoking, Stress Disorders, Post-Traumatic
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
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)
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
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
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
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
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
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
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
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.
- First posted7 Jun 2019
- Study start7 Nov 2019
- Primary completion8 Oct 2025
- Study completion8 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eric A Dedert, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPT-SMART for Treatment of PTSD and Cigarette Smoking
- ClinicalTrials.gov ID
- NCT03978442
- Acronym / sponsor ID
- CPT-SMART / MHBB-008-18F
- Conditions
- Smoking, Stress Disorders, Post-Traumatic
- Keywords
- Stress Disorders, Post-Traumatic, Smoking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 8 Oct 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, two-arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| CPT-SMART | Experimental | Behavioral: Smoking Cessation Cognitive Behavioral Therapy (CBT), Drug: Bupropion, Behavioral: Cognitive Processing Therapy, Behavioral: Smoking Abstinence Reinforcement TherapyCOGNITIVE 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. |
| Combined Contact Yoked Control | Active comparator | Behavioral: Smoking Cessation Cognitive Behavioral Therapy (CBT), Drug: Bupropion, Behavioral: Cognitive Processing Therapy, Behavioral: Yoked Contingency ManagementCOMBINED 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Cessation Cognitive Behavioral Therapy (CBT)Also: CBT12 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. | Behavioural | CPT-SMART, Combined Contact Yoked Control |
| BupropionAlso: ZybanAll 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. | Drug | CPT-SMART, Combined Contact Yoked Control |
| Cognitive Processing TherapyAlso: CPT12 sessions of CPT, which is a well-established trauma-focused psychotherapy for PTSD that has demonstrated efficacy and effectiveness in Veterans. | Behavioural | CPT-SMART, Combined Contact Yoked Control |
| Smoking Abstinence Reinforcement TherapyAlso: SMARTMonetary reinforcement for smoking abstinence that is bioverified by breath carbon monoxide and saliva samples. | Behavioural | CPT-SMART |
| Yoked Contingency ManagementAlso: Control CMParticipants in the yoked control will receive the monetary reinforcement of their yoked participant regardless of smoking abstinence or session attendance. | Behavioural | Combined Contact Yoked Control |
Primary outcome
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
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
8 secondary outcomes
Number of Participants Whose Self-report of 30 Day Point Prevalence Abstinence From Smoking is Bioverified
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
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
Time frame: 4 month follow-up, up to 5 months from baseline
Number of Participants Who Self-report Prolonged Abstinence
Time frame: 4 month follow-up, up to five months from baseline
Number of Participants Who Self-report Prolonged Abstinence
Time frame: 6 month follow-up, up to 7 months from baseline
Number of Participants Who Self-report Early Abstinence
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
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
Time frame: Measured at the post-treatment visit (2 weeks after treatment completed), up to 4.5 months from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We do not plan to attend individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric A Dedert, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
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.