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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
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Timeline
Screening ~ 2 days16 visits
Treatment ~ 6 weeks12 visits
Follow Up ~ 5 months3 visits
Screening ~ 2 days
Treatment ~ 6 weeks
Follow Up ~5 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
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 moreTrial 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
~3770
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,950 Total Patients Enrolled
Eric A Dedert, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
1 Previous Clinical Trials
69 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have posttraumatic stress disorder (PTSD).You are a military veteran.You have been a smoker for the past year.I am willing to try quitting smoking and undergo therapy for trauma.You have smoked at least 10 cigarettes every day for the past year.I am between 18 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: CPT-SMART
- Group 2: Combined Contact Yoked Control
Awards:
This trial has 5 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 5 Months after you stop receiving the treatment.
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