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MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents

NCT06353282 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-04-10

No results posted yet for this study

Summary

The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms.

Conditions

  • PTSD, Post Traumatic Stress Disorder
  • Adolescents
  • Psychotherapy

Interventions

DRUG

MDMA

MDMA will be dosed in pre-filled capsules and administered orally to participants in two fixed doses - an 80mg dose following the fourth session and a 120mg dose following the ninth session of MDMA to each participant. MDMA experimental medication administration session 1 (8 hours); MDMA experimental medication session 2 (8 hours). Participants will be required to remain in the therapy room for the duration of the experimental medication sessions without the youths' parent/guardian present. The parent/guardian will be invited to attend integration sessions and must be available to drop off and pick up the participant.

BEHAVIORAL

Psychotherapy

Treatment session order: Four weekly 90-minute experimental medication preparation psychotherapy sessions; four weekly 90-minute psychotherapy integration sessions, starting the day following the preceding experimental medication session; and Five weekly 90-minute psychotherapy integration sessions, starting the day following the preceding experimental medication session.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-01-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT06353282 on ClinicalTrials.gov