Smoking Cessation Cognitive Behavioral Therapy (CBT) for Post-Traumatic Stress Disorder (PTSD)
(CPT-SMART Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop taking my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must be willing to use bupropion (a medication to help quit smoking) and not receive other behavioral smoking counseling or trauma-focused therapy during the study.
What data supports the effectiveness of the drug bupropion for smoking cessation?
Is the combination of Cognitive Processing Therapy, Smoking Cessation Counseling, and Bupropion safe for humans?
Bupropion, used for smoking cessation, is generally considered safe with minimal side effects, but it carries warnings about potential risks of suicidal behavior and depression. Regulatory agencies find its benefits outweigh the risks, but patients should be monitored for neuropsychiatric symptoms, especially if they have psychiatric conditions.12367
What makes this treatment for PTSD and smoking unique?
This treatment is unique because it combines Cognitive Processing Therapy (a type of talk therapy for PTSD), Smoking Cessation Counseling, and the medication Bupropion, which is known to help with smoking cessation and depression. This comprehensive approach addresses both PTSD and smoking simultaneously, which is not commonly done in standard treatments.12589
Research Team
Eric A Dedert, PhD
Principal Investigator
Durham VA Medical Center, Durham, NC
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Cognitive Processing Therapy combined with Smoking Abstinence Reinforcement Therapy, including cognitive-behavioral counseling, bupropion, and contingency management
Follow-up
Participants are monitored for smoking abstinence and treatment engagement
Treatment Details
Interventions
- Bupropion (Drug)
- Cognitive Processing Therapy (Behavioural Intervention)
- Smoking Abstinence Reinforcement Therapy (Behavioural Intervention)
- Smoking Cessation Cognitive Behavioral Therapy (CBT) (Behavioural Intervention)
- Yoked Contingency Management (Behavioural Intervention)
Bupropion is already approved in Canada for the following indications:
- Smoking cessation
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Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Dr. Grant Huang
VA Office of Research and Development
Acting Chief Research and Development Officer
PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences
Dr. Erica M. Scavella
VA Office of Research and Development
Chief Medical Officer since 2022
MD from University of Massachusetts School of Medicine