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NCT03978442 · ClinicalTrials.gov registry record · Phase 4
CPT-SMART for Treatment of PTSD and Cigarette Smoking
A Phase 4 study of Smoking and Stress Disorders, Post-Traumatic, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT03978442 is a Phase 4 study of Smoking and Stress Disorders, Post-Traumatic that has completed, run by VA Office of Research and Development. The registered enrollment target is 120 participants, below the 454-participant average among 123 other Smoking trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03978442, a Phase 4 study of Smoking and Stress Disorders, Post-Traumatic, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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). 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 treat
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Processing Therapy
- DRUG Bupropion
- BEHAVIORAL Smoking Cessation Cognitive Behavioral Therapy (CBT)
- BEHAVIORAL Smoking Abstinence Reinforcement Therapy
- BEHAVIORAL Yoked Contingency Management
Study Locations (1)
North Carolina
- Durham VA Medical Center, Durham, NC - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-11-07 |
| Est. Completion | 2025-10-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03978442
The ClinicalTrials.gov registry entry for NCT03978442 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 454-participant average among 123 other Smoking trials with a reported enrollment target (74% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Smoking appearing as the primary indexed condition, and to 5 interventions - of which Cognitive Processing Therapy is the first listed.
NCT03978442 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT03978442 about?
NCT03978442 is a clinical study titled "CPT-SMART for Treatment of PTSD and Cigarette Smoking". 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...
What is the current status of trial NCT03978442?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2019-11-07. Estimated completion is 2025-10-08.
What conditions does trial NCT03978442 study?
This clinical trial studies the following conditions: Smoking, Stress Disorders, Post-Traumatic.
What interventions are being tested in trial NCT03978442?
The interventions under investigation include: Cognitive Processing Therapy (BEHAVIORAL), Bupropion (DRUG), Smoking Cessation Cognitive Behavioral Therapy (CBT) (BEHAVIORAL), Smoking Abstinence Reinforcement Therapy (BEHAVIORAL), Yoked Contingency Management (BEHAVIORAL).
Who is sponsoring clinical trial NCT03978442?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03978442 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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