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NCT03605342 · ClinicalTrials.gov registry record · Phase 2
Optimal Treatment of Veterans With PTSD and Comorbid OUD
A Phase 2 study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT03605342: Clinical Trial Phase 2 study, sponsored by VA Office of Research and Development.
NCT03605342 is a Phase 2 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03605342, a Phase 2 study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
The objective of this study is to test a standard psychotherapy for PTSD in Veterans who also suffer from Opiate Use Disorder (OUD). Specifically, this study will test whether Cognitive Processing Therapy (CPT)-C is more effective in treating PTSD, compared to a control group (Individual Drug Counseling (IDC); which approximates treatment as usual), among Veterans with PTSD and comorbid OUD who are maintained on buprenorphine. The study has three phases. In Phase I: induction to buprenorphine/naloxone (BUP/NLX) maintenance. Phase II: treatment. During this phase participants will be randomly assigned to CPT-C or IDC for 12 weeks. They will be seen weekly for psychotherapy and also regularly (weekly, then biweekly, then monthly) for buprenorphine management, symptom evaluation, and medication refill. After completing treatment participants will be referred to a buprenorphine clinic for ongoing care. Phase III: follow-up. Approximately 160 male and female Veterans (18-65 years old) with PTSD and comorbid opiate use disorder (OUD) will be enrolled in this study. Recruitment will be through VA clinics, word-of-mouth, referrals from area programs and by advertisement. Veterans who are interested will complete a brief pre-screening and detailed in-person screening. After completing the screening process, all eligible participants will be started on buprenorphine maintenance and once withdrawal symptoms are stabilized, participants will be randomly assigned to 1 of 2 conditions (CPT-C or IDC) for 12 weeks. Veterans who are already on BUP/NLX will be allowed to participate and will start at Phase II of the study, after completing the screening.
Primary Outcome
Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) is a structured diagnostic interview. The scale also assesses social and occupational functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. The CAPS-5 requires approximately 40
Interventions
- DRUG Buprenorphine
- BEHAVIORAL Cognitive Processing Therapy (CPT)
- BEHAVIORAL Individual Drug Counseling (IDC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2023-04-14 |
| Phase | Phase 2 |
Why NCT03605342 stopped before completion
NCT03605342 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 3 interventions - of which Buprenorphine is the first listed.
NCT03605342 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03605342 about?
NCT03605342 is a clinical study titled "Optimal Treatment of Veterans With PTSD and Comorbid OUD". The objective of this study is to test a standard psychotherapy for PTSD in Veterans who also suffer from Opiate Use Disorder (OUD). Specifically, this study will test whether Cognitive Processing Therapy (CPT)-C is more effective in treating PTSD, compared to a control group (Individual Drug Counse...
What is the current status of trial NCT03605342?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2018-10-01. Estimated completion is 2023-04-14.
What interventions are being tested in trial NCT03605342?
The interventions under investigation include: Buprenorphine (DRUG), Cognitive Processing Therapy (CPT) (BEHAVIORAL), Individual Drug Counseling (IDC) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03605342?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03605342's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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