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MDMA Psychotherapy for Adolescence

Phase 2

Waitlist Available

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, one month post experimental session, and 3 and 6 months post-treatment. through study completion, an average of 9 months

Awards & highlights

Study Summary

This trial aims to test if using MDMA along with therapy is safe and possible for treating PTSD that has not responded to other treatments. They also want to see if it helps with PTSD symptoms, depression,

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

MDMA may cause side effects like anxiety, changes in mood, headaches, fatigue, muscle tension and could potentially affect heart rate and blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, one month post experimental session, and 3 and 6 months post-treatment. through study completion, an average of 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, one month post experimental session, and 3 and 6 months post-treatment. through study completion, an average of 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, one month post experimental session, and 3 and 6 months post-treatment. through study completion, an average of 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in body temperature

Change in pulse

Changes in blood pressure

+2 more

Secondary outcome measures

Mean change in PTSD symptom severity via the Child PTSD Symptom Scale

Mean change in PTSD symptom severity via the Clinician-Administered PTSD Scale (CAPS-CA-5)

Mean change in anxiety symptom severity via the Generalized Anxiety Disorder 7-item (GAD-7)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: MDMA PsychotherapyExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psychotherapy

2020

Completed Phase 3

~3120

MDMA

2001

Completed Phase 2

~390

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,533 Previous Clinical Trials

10,265,558 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial available to those who have reached the age of majority?

"The investigation is open to individuals who have surpassed their 16th year but not reached the age of 17."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"According to information on clinicaltrials.gov, this particular trial is currently not open for patient recruitment. The trial was originally listed on 1st July 2025 and last updated on 5th April 2024. Despite its closure, there are a total of 447 ongoing trials that are actively seeking participants at present."

Answered by AI

What are the known risks associated with utilizing MDMA-assisted therapy in patients?

"Based on the phase of this trial, our assessment at Power rates the safety of MDMA Psychotherapy as a 2. This score reflects some existing safety data with no evidence yet supporting its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents

Jessica Jeffrey, MD, MPH, MBA 2025. "MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06353282.