Trial · NCT03605342
Optimal Treatment of Veterans With PTSD and Comorbid OUD
NCT03605342, Phase 2, Terminated, VA Office of Research and Development; results first posted 2024-08-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Optimal Treatment of Veterans With PTSD and Comorbid OUD. Trials, record NCT03605342. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03605342
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimal Treatment of Veterans With PTSD and Comorbid OUD
- NCT number
- NCT03605342
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Post-Traumatic Stress Disorders, Opiate Use Disorder
- Interventions
- Buprenorphine, Cognitive Processing Therapy (CPT), Individual Drug Counseling (IDC)
- First posted
- 2018-07-30
- Last updated
- 2024-08-19
- Results first posted
- 2024-08-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinician Administered PTSD Scale (CAPS-5) | Baseline | 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 minutes to administer. Scores can range from 0 (minimum score) - 80 (maximum score) with higher scores indicating greater severity. (0-19=Asymptomatic/few symptoms very mild PTSD, 20-39=Sub-threshold/mild PTSD, 40-59=Threshold PTSD/moderate PTSD, 60-79=Severe PTSD, 80=Extreme PTSD) |
| Primary | PTSD Checklist - Military Version (PCL-5) Total Score | Baseline | PCL-5 will be used to collect information on PTSD symptoms. The PCL-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." Items are summed to provide a total severity score (range 0-80). PCL-5 score between 31-33 is indicative of PTSD. |
| Primary | Clinician Administered PTSD Scale (CAPS-5) | Week 12 | 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 minutes to administer. Scores can range from 0 (minimum score) - 80 (maximum score) with higher scores indicating greater severity. (0-19=Asymptomatic/few symptoms very mild PTSD, 20-39=Sub-threshold/mild PTSD, 40-59=Threshold PTSD/moderate PTSD, 60-79=Severe PTSD, 80=Extreme PTSD) |
| Primary | PTSD Checklist - Military Version (PCL-5) Total Score | Week 12 | PCL-5 will be used to collect information on PTSD symptoms. The PCL-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." Items are summed to provide a total severity score (range 0-80). PCL-5 score between 31-33 is indicative of PTSD. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinician Administered PTSD Scale (CAPS-5) | Baseline | units on a scale | MEAN | |
| PRIMARY | PTSD Checklist - Military Version (PCL-5) Total Score | Baseline | units on a scale | MEAN | |
| PRIMARY | Clinician Administered PTSD Scale (CAPS-5) | Week 12 | units on a scale | MEAN | |
| PRIMARY | PTSD Checklist - Military Version (PCL-5) Total Score | Week 12 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinician Administered PTSD Scale (CAPS-5) | Buprenorphine + CPT-C | 31.95 | Standard Error 2.62 | units on a scale | |
| Clinician Administered PTSD Scale (CAPS-5) | Buprenorphine + IDC | 34.38 | Standard Error 2.76 | units on a scale | |
| PTSD Checklist - Military Version (PCL-5) Total Score | Buprenorphine + CPT-C | 44.80 | Standard Error 3.66 | units on a scale | |
| PTSD Checklist - Military Version (PCL-5) Total Score | Buprenorphine + IDC | 45.44 | Standard Error 3.86 | units on a scale | |
| Clinician Administered PTSD Scale (CAPS-5) | Buprenorphine + CPT-C | 29.59 | Standard Error 3.64 | units on a scale | |
| Clinician Administered PTSD Scale (CAPS-5) | Buprenorphine + IDC | 27.12 | Standard Error 3.25 | units on a scale | |
| PTSD Checklist - Military Version (PCL-5) Total Score | Buprenorphine + CPT-C | 34.17 | Standard Error 4.23 | units on a scale | |
| PTSD Checklist - Military Version (PCL-5) Total Score | Buprenorphine + IDC | 29.39 | Standard Error 4.30 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Buprenorphine + CPT-C | 20 | |
| Overall Study | STARTED | Buprenorphine + IDC | 18 | |
| Overall Study | COMPLETED | Buprenorphine + CPT-C | 10 | |
| Overall Study | COMPLETED | Buprenorphine + IDC | 10 | |
| Overall Study | NOT COMPLETED | Buprenorphine + CPT-C | 10 | |
| Overall Study | NOT COMPLETED | Buprenorphine + IDC | 8 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buprenorphine + CPT-C | 0 | 20 |
| Total, all-cause mortality | Buprenorphine + IDC | 0 | 18 |
| Total, other adverse events | Buprenorphine + CPT-C | 0 | 20 |
| Total, other adverse events | Buprenorphine + IDC | 0 | 18 |
| Total, serious adverse events | Buprenorphine + CPT-C | 0 | 20 |
| Total, serious adverse events | Buprenorphine + IDC | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38624259 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Buprenorphine + CPT-C vs Buprenorphine + IDC: deaths from any cause | Trial comparisons |
| Buprenorphine + CPT-C vs Buprenorphine + IDC: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03605342
GET https://conductscience.org/api/trials/v1/NCT03605342/registered