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Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans

NCT05173831 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-10-30

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if MDMA-assisted group therapy is safe and effective in in people with at least moderate PTSD.

The main question it aims to answer is: Do two sessions of open-label MDMA-assisted group therapy reduce PTSD symptoms?

Participants will undergo non-drug preparatory therapy sessions before their MDMA-assisted therapy sessions. After, they will undergo non-drug integrative therapy sessions.

Conditions

Interventions

DRUG

Midomafetamine

Initial dose of 120 mg midomafetamine HCl and optional supplemental dose of 60 mg 1.5 to 2 hours later

BEHAVIORAL

Therapy

Manualized therapy performed by therapist team

Sponsors & Collaborators

Principal Investigators

  • Chris Stauffer, MD · Associate Professor of Psychiatry at Oregon Health & Science University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05173831 on ClinicalTrials.gov