MDMA-Assisted Psychotherapy for PTSD in Adolescents

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, Los Angeles

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adolescents with PTSD that hasn't improved after trying other treatments. Participants must be struggling with severe symptoms of trauma, depression, or anxiety despite previous therapy.

Inclusion Criteria

Participants may also meet criteria for a mood or anxiety disorder

Participants must meet DSM-5 criteria for current PTSD in response to a traumatic experience

I am 16 or 17 years old.

Exclusion Criteria

Participants who appear to reside within an unsupportive and/or chaotic family structure

Participants outside the specified weight range

Participants meeting DSM 5 criteria for a substance use disorder

Participant Groups

The study is testing whether a combination of MDMA (a drug known for its empathogenic effects) and psychotherapy can safely help teens who haven't gotten better with standard PTSD treatments.

Group I: MDMA Psychotherapy Experimental Treatment 2 Interventions

Open-label fixed-dose trial whereby 10 youth with treatment-resistant PTSD will be recruited. Treatment-resistant depression is defined as having continued DSM-5 diagnosis of PTSD following at least 3 months of psychotherapy and (either separately or combined) at least 3 months SSRI pharmacotherapy. Prior to 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.

MDMA is already approved in United States for the following indications:

🇺🇸 Approved in United States as MDMA for:

• Posttraumatic stress disorder (PTSD)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UCLA Semel Institute for Neuroscience and Human Behavior Los Angeles, CA

Who Is Running the Clinical Trial?

University of California, Los Angeles Lead Sponsor

References