NCT06353282

MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents

3, 4-methylenedioxymethamphetamine (MDMA) for Treatment-resistant Post-traumatic Stress Disorder (PTSD) in Adolescents

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 16 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is an open-label fixed dose trial whereby youth with treatment-resistant post-traumatic stress disorder (PTSD) will be recruited. Treatment-resistant depression is defined as having continued Diagnostic Statistical Manual (DSM-5) diagnosis of PTSD following at least 3 months of psychotherapy and (either separately or combined) at least 3 months of SSRI pharmacotherapy. Before entering the trial, youth will undergo a preliminary medical and psychiatric screening to determine eligibility. Eligible youth will then proceed to 3-month MDMA-assisted psychotherapy, which includes 13 sessions of psychotherapy with two MDMA experimental medication sessions of 80mg and 120mg, respectively. Study assessments will include a baseline assessment, weekly assessments throughout the course of the treatment trial, and assessments at 3 months and 6 months post-treatment.

Conditions

• PTSD, Post Traumatic Stress Disorder
• Adolescents
• Psychotherapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-01-31
• Completion: 2026-12-31
• First posted: 2024-04-09
• Last updated: 2025-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study