Trial · NCT07118839
MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder
NCT07118839, Phase 2, Phase 3, Recruiting, VA Office of Research and Development
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder. Trials, record NCT07118839. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07118839
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder
- NCT number
- NCT07118839
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 80 participants, estimated
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Post Traumatic Stress Disorder, Alcohol Use Disorder
- Interventions
- Full Dose MDMA, MDMA-Assisted psychotherapy, Active Placebo Dose MDMA
- First posted
- 2025-08-12
- Last updated
- 2026-06-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score | from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline) | To evaluate the efficacy of MDMA-assisted therapy (MDMA-AT) in reducing PTSD symptom severity in participants with co-occurring PTSD and Alcohol Use Disorder (AUD), as measured by the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score (past 30 days) from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline). The CAPS-5 total severity score ranges from 0 to 80 with higher scores reflecting worse PTSD symptom severity. |
| Secondary | Timeline Follow-Back (TLFB): Drinks per drinking day (past 90 days) | from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline) | To evaluate the efficacy of MDMA-assisted therapy in reducing alcohol use in participants with co-occurring PTSD and Alcohol Use Disorder (AUD), as measured by the change in drinks per drinking day on the Timeline Follow-Back (TLFB; past 90 days) from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline). |
| Secondary | Timeline Follow-Back (TLFB): Number of heavy drinking days (past 90 days) | from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline) | To evaluate the efficacy of MDMA-assisted therapy in reducing alcohol use in participants with co-occurring PTSD and Alcohol Use Disorder (AUD), as measured by the change in the number of heavy drinking days on the Timeline Follow-Back (TLFB; past 90 days) from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline). |
| Secondary | Timeline Follow-Back (TLFB): Percent days abstinent (past 90 days) | from Baseline (Visit 0) to Visit 16 (approximately 16 weeks post-baseline) | To evaluate the efficacy of MDMA-assisted therapy in reducing alcohol use in participants with co-occurring PTSD and Alcohol Use Disorder (AUD), as measured by the change in percent days abstinent on the Timeline Follow-Back (TLFB; past 90 days) from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline). |
| Secondary | Inventory of Psychosocial Functioning (IPF) total average score | from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline) | To assess the impact of MDMA-assisted therapy on psychosocial functioning in participants with co-occurring PTSD and Alcohol Use Disorder (AUD), as measured by the change in Inventory of Psychosocial Functioning (IPF) total score (past 30 days) from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline). Items on the IPF are rated on a 1-7 scale with scales averaged across items; total score range is 1-7. Higher scores reflect worse psychosocial functioning (i.e., greater impairment). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT07118839
GET https://conductscience.org/api/trials/v1/NCT07118839/registered