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MDMA-assisted Massed Prolonged Exposure for PTSD

NCT06117306 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-24

No results posted yet for this study

Summary

The overall objective of this study is to pilot the VASDHS-adapted Emory MDMA-PE Protocol (aE-MDMA-PE) and assess the effect on clinician-rated PTSD symptoms in veterans who receive different doses of MDMA.

Conditions

  • Post-Traumatic Stress Disorder

Interventions

DRUG

3,4 Methylenedioxymethamphetamine

1 MDMA session

BEHAVIORAL

Prolonged Exposure

12 90-minute PE sessions; initial two sessions both occurring during the first treatment visit, third and fourth sessions occurring during the MDMA session, and the remaining sessions occurring daily or every other day

Sponsors & Collaborators

  • San Diego Veterans Healthcare System

    collaborator FED

  • National Center for PTSD

    collaborator FED

  • White River Junction VA Medical Center

    collaborator UNKNOWN

  • Lykos Therapeutics

    collaborator INDUSTRY

  • Healing Breakthrough

    lead UNKNOWN

Principal Investigators

  • Leslie Morland, Psy.D. · San Diego Veterans Affairs Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-25
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT06117306 on ClinicalTrials.gov