Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans
Brief Summary
This Phase 2, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans. The study will be conducted in up to N=18 participants, recruited in three cohorts of six participants and receive therapy sessions throughout their participation in these groups.
Study Design
| Study type: | Interventional |
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| Status: | Not yet recruiting |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 18 () |
| Funded by: | Other |
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Clinical Trial Dates
| Start date: | Jun 01, 2022 | |
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| Primary Completion: | Jun 01, 2023 | |
| Completion Date: | Jun 01, 2023 | |
| Study First Posted: | Dec 30, 2021 | |
| Last Updated: | Dec 30, 2021 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
To further assess the feasibility, efficacy, and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor is conducting a phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA, along with non-drug preparatory and integrative therapy administered in both individual and group sessions. The Primary Outcome measure, the Clinician Administered PTSD Scale (CAPS-5), evaluates changes in PTSD symptom severity and is assessed by a blinded centralized Independent Rater (IR) pool. The therapeutic approach will combine manualized MDMA-assisted therapy for PTSD with group therapy components.
Eligibility Criteria
| Sex: | All |
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More Details
| NCT Number: | NCT05173831 |
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| Acronym: | MPG1 |
| Other IDs: | MPG1 |
| Study URL: | https://ClinicalTrials.gov/show/NCT05173831 |
Last updated: Jun 17, 2022