Trial · NCT07569159
MDMA Therapy in Veterans With PTSD
NCT07569159, Phase 2, Recruiting, Sunstone Medical
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MDMA Therapy in Veterans With PTSD. Trials, record NCT07569159. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07569159
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MDMA Therapy in Veterans With PTSD
- NCT number
- NCT07569159
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 52 participants, estimated
- Lead sponsor
- Sunstone Medical
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- MDMA
- First posted
- 2026-05-06
- Last updated
- 2026-07-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability | 15 months | To assess the safety and tolerability of individual and group MDMA-assisted therapy in adult veterans with PTSD using Incidence and occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from signing of ICF until the EOS Visit. |
| Primary | C-SSRS | 15 months | Incidence of changes in suicidal ideation/behavior (measured using the Columbia-Suicide Severity Rating Scale \[C-SSRS\]) score at all visits from Baseline to EOS Visit. |
| Secondary | Efficacy of Therapy | 15 months | To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the Clinician Administered PTSD Scale. (CAPS-5) |
| Secondary | Effect of Therapy | 15 months | To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the Sheehan Disability Scale. (SDS) |
| Secondary | Efficacy of Therapy | 15 months | To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the PTSD Checklist for DSM-5.(PCL-5) |
| Secondary | Efficacy of Therapy | 15 months | To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the State-Trait Anxiety Inventory. (STAI) |
| Secondary | Efficacy of Therapy | 15 months | To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the Quick Inventory of Depressive Symptomatology- Self-Report. ( QIDS-SR-16) |
| Secondary | Effect of Therapy | 15 months | To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the EQ-5D-5L. |
| Secondary | Effects of Therapy | 15 months | To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the Clinician Administered PTSD Scale. (CAPS-5) |
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/NCT07569159
GET https://conductscience.org/api/trials/v1/NCT07569159/registered