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MDMA-Assisted Psychotherapy for PTSD in Adolescents

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MJ
Overseen ByMarc J Weintraub, Ph.D.
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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.
See 8 more

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
See 12 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: MDMA PsychotherapyExperimental Treatment2 Interventions

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

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Approved in United States as MDMA for:

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Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+
Unbiased ResultsWe believe in providing patients with all the options.
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