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Smoking Cessation Cognitive Behavioral Therapy (CBT) for Post-Traumatic Stress Disorder (PTSD) (CPT-SMART Trial)

Phase 4
Recruiting
Led By Eric A Dedert, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is between the ages of 18 and 80
Be older than 18 years old
Timeline
Screening 2 days
Treatment 6 weeks
Follow Up 5 months
Awards & highlights

CPT-SMART Trial Summary

This trial will test a treatment that combines cognitive processing therapy with cognitive-behavioral counseling for smoking cessation, contingency management, and smoking cessation medication to see if it is more effective than just cognitive processing therapy for reducing smoking among veterans with PTSD.

Who is the study for?
Veterans aged 18-80 who smoke at least ten cigarettes daily for the past year, are willing to try quitting and undergo trauma-focused therapy, and currently have PTSD. Participants must speak and write English.Check my eligibility
What is being tested?
The trial is testing CPT-SMART, a combination of Cognitive Processing Therapy (CPT) for PTSD with smoking cessation treatments including behavioral counseling, medication (Bupropion), and Contingency Management that rewards abstinence from smoking.See study design
What are the potential side effects?
Possible side effects include those related to Bupropion such as insomnia, dry mouth, headaches; CBT may initially increase emotional distress due to confronting traumatic memories.

CPT-SMART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 80 years old.

CPT-SMART Trial Timeline

Screening ~ 2 days
Treatment ~ 6 weeks
Follow Up ~5 months
This trial's timeline: 2 days for screening, 6 weeks for treatment, and 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Number of participants who attended eight or more sessions of combined CPT and CBT for smoking
Number of participants who self-report early abstinence
Number of participants who self-report prolonged abstinence
+3 more

CPT-SMART Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CPT-SMARTExperimental Treatment4 Interventions
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.
Group II: Combined Contact Yoked ControlActive Control4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupropion
FDA approved
Cognitive Processing Therapy
2016
N/A
~3400

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,483 Total Patients Enrolled
Eric A Dedert, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
1 Previous Clinical Trials
69 Total Patients Enrolled

Media Library

Bupropion Clinical Trial Eligibility Overview. Trial Name: NCT03978442 — Phase 4
Post-Traumatic Stress Disorder Research Study Groups: CPT-SMART, Combined Contact Yoked Control
Post-Traumatic Stress Disorder Clinical Trial 2023: Bupropion Highlights & Side Effects. Trial Name: NCT03978442 — Phase 4
Bupropion 2023 Treatment Timeline for Medical Study. Trial Name: NCT03978442 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have enrolled in this medical research?

"Indeed, records on clinicaltrials.gov indicate that this trial is actively searching for participants to join the study which was first published on November 7th 2019 and recently updated August 23rd 2022. The researchers have set out to recruit 120 patients from one site."

Answered by AI

Does the research team seek volunteers who are of twenty-one years or older?

"This clinical trial necessitates that enrollees meet the age criteria of 18-80. Simultaneously, there are 41 studies targeting minors and 353 research projects for elderly patients."

Answered by AI

Are there eligibility requirements for partaking in this research?

"This clinical trial requires potential participants to have suffered from moral injury, and be within the ages of 18-80. In total, 120 individuals are needed for this study."

Answered by AI

What type of results can be expected from a Smoking Cessation Cognitive Behavioral Therapy (CBT) program?

"Seasonal Affective Disorder (SAD), nicotine addiction, and smoking can all be remedied through Smoking cessation Cognitive Behavioral Therapy (CBT)."

Answered by AI

Could the application of Smoking Cessation Cognitive Behavioral Therapy (CBT) prove deleterious to individuals?

"There is evidence to suggest that the safety of Smoking cessation Cognitive Behavioral Therapy (CBT) warrants a score of 3. This treatment has been approved after undergoing rigorous Phase 4 trials."

Answered by AI

Are there any enrollment opportunities for this clinical experiment?

"The publically available records on clinicaltrials.gov show that this experiment is still seeking participants, having been posted to the site in November 2019 and most recently updated in August 2022."

Answered by AI

Are there any other precedents of Smoking Cessation Cognitive Behavioral Therapy (CBT) being employed?

"At present, there are 31 active trials for [Smoking cessation](https://www.withpower.com/clinical-trials/smoking-cessation) Cognitive Behavioral Therapy (CBT) with 10 of them in the final stage. Most locations conducting this research are based around New Haven, Connecticut; however, 283 sites across the globe have been employed to carry out studies into smoking cessation CBT."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Durham VA Medical Center, Durham, NC
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Earn extra money & stop smoking. 2 birds**1😀.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
CPT-SMART for Treatment of PTSD and Cigarette Smoking
2019. "CPT-SMART for Treatment of PTSD and Cigarette Smoking". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03978442.
All > Smoking > Wellbutrin
~22 spots leftby Apr 2025
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