MDMA-Assisted Psychotherapy for PTSD in Adolescents

Overseen By Marc J Weintraub, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Los Angeles

Must not be taking: Psychoactive drugs, Benzodiazepines

Disqualifiers: Psychotic disorder, Cardiovascular conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 17

Duration: 12 weeks

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo 3-month MDMA-assisted psychotherapy, including 13 psychotherapy sessions and two MDMA sessions

12 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 3 and 6 months post-treatment

Treatment Details

Interventions

• MDMA

Trial Overview 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.

Participant Groups

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)

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+