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Psychedelic

MDMA-Assisted Therapy for PTSD (MPVA6 Trial)

Phase 2
Waitlist Available
Led By Rachel Yehuda
Research Sponsored by MAPS Public Benefit Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are at least 18 years old.
Are able to swallow pills.
Must not have
Have history of hyponatremia or hyperthermia
Have symptomatic liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - 4 months from enrollment
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the effectiveness of different numbers of MDMA-assisted therapy sessions in U.S. military veterans with moderate to severe PTSD. MDMA helps patients feel more open and comfortable during therapy, aiding in the processing of traumatic memories. MDMA-assisted psychotherapy began in the 1980s but was shelved due to public health concerns.

Who is the study for?
This trial is for U.S. military veterans aged 18 or older with moderate chronic PTSD. Participants must not be in other trials, able to swallow pills, and fluent in the study site's language. They need a contact person in case of emergencies and agree to recorded sessions and overnight stays post-treatment.
What is being tested?
The study compares the effectiveness of two versus three active MDMA-assisted psychotherapy sessions for treating PTSD in veterans. It's an open-label, randomized trial where participants will receive either two or three doses of MDMA during therapy at a VA clinic.
What are the potential side effects?
MDMA can cause side effects like anxiety, headache, fatigue, muscle tension, insomnia, nausea, confusion after use (known as 'Tuesday Blues'), mood swings and may increase the risk of suicidal thoughts especially if there's a history of mental health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can swallow pills.
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I have been diagnosed with moderate PTSD.
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I can fluently speak and read the main language used at the study site.
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I can swallow pills.
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I have been diagnosed with moderate PTSD.
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I can fluently speak and read the main language used at the study site.
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I am 18 years old or older.
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I agree to stay overnight at the study site and follow all study procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had low sodium levels or very high body temperature in the past.
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I have symptoms caused by liver problems.
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I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.
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My high blood pressure is not under control.
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I weigh less than 48 kg.
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I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - 4 months from enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 4 months from enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in CAPS-5 Total Severity Score from Baseline to Visit 13 for 2 Session Group
Change in CAPS-5 Total Severity Score from Baseline to Visit 17 for 3 Session Group
Secondary study objectives
Change in Sheehan Disability Scale (SDS) from Baseline to Visit 13 for 2 Session Group
Change in Sheehan Disability Scale (SDS) from Baseline to Visit 17 for 3 Session Group

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Two sessions of MDMA-assisted therapyActive Control2 Interventions
Two experimental sessions of MDMA-assisted therapy
Group II: Three sessions of MDMA-assisted therapyActive Control2 Interventions
Three experimental sessions of MDMA-assisted therapy

Find a Location

Who is running the clinical trial?

MAPS Public Benefit CorporationLead Sponsor
29 Previous Clinical Trials
878 Total Patients Enrolled
Lykos TherapeuticsLead Sponsor
42 Previous Clinical Trials
1,250 Total Patients Enrolled
Multidisciplinary Association for Psychedelic StudiesLead Sponsor
39 Previous Clinical Trials
1,184 Total Patients Enrolled
Rachel YehudaPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

MDMA (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT04784143 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Two sessions of MDMA-assisted therapy, Three sessions of MDMA-assisted therapy
Post-Traumatic Stress Disorder Clinical Trial 2023: MDMA Highlights & Side Effects. Trial Name: NCT04784143 — Phase 2
MDMA (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04784143 — Phase 2
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04784143 — Phase 2
~6 spots leftby Dec 2025
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