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Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD

NCT04968938 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-11-01

No results posted yet for this study

Summary

The purpose of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with PTSD.

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

Participants will undergo three non-drug preparatory therapy sessions followed by two open-label MDMA-assisted therapy sessions. After, participants will undergo three non-drug integrative therapy sessions.

Conditions

Interventions

DRUG

midomafetamine

80 mg or 120 mg midomafetamine HCl followed by a 40 mg supplement dose

BEHAVIORAL

Therapy

Manualized therapy

Sponsors & Collaborators

Principal Investigators

  • Devon Christie, MD · Department of Medicine, University of British Columbia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-08-31
Completion
2023-08-31
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 NCT04968938 on ClinicalTrials.gov