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Experimental: MDMA-assisted psychotherapy for Post-Traumatic Stress Disorder

Phase 3
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 18 weeks post enrollment confirmation
Awards & highlights

Study Summary

This trial will study whether MDMA-assisted psychotherapy can help people with PTSD compared to regular psychotherapy.

Eligible Conditions
  • Post-Traumatic Stress Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 18 weeks post enrollment confirmation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 18 weeks post enrollment confirmation 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 From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-V (CAPS-5)
Secondary outcome measures
Change From Baseline to Primary Endpoint in Adapted Sheehan Disability Scale (SDS) Total Score

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: MDMA-assisted psychotherapyExperimental Treatment2 Interventions
Administration of 80 to 120 mg MDMA in combination with psychotherapy, followed by a supplemental half-dose of 40 or 60 mg MDMA offered 1.5 to 2 hrs after the initial dose, respectively.
Group II: Placebo Comparator: PlaceboPlacebo Group2 Interventions
Administration of inactive placebo in combination with psychotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midomafetamine
2014
Completed Phase 3
~310
Therapy
2014
Completed Phase 3
~990

Find a Location

Who is running the clinical trial?

MAPS Public Benefit CorporationLead Sponsor
29 Previous Clinical Trials
1,202 Total Patients Enrolled
Lykos TherapeuticsLead Sponsor
41 Previous Clinical Trials
1,539 Total Patients Enrolled
Multidisciplinary Association for Psychedelic StudiesLead Sponsor
39 Previous Clinical Trials
1,513 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Missouri
New York
California
How old are they?
65+
18 - 65
What site did they apply to?
San Francisco Insight and Integration Center
University of Wisconsin at Madison
New School Research LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
The International Journal of Psychiatry in MedicineJournal
Assessing Psychiatric Impairment in Primary Care with the Sheehan Disability Scale
Leon, Andrew C., Mark Olfson, Laura Portera, Leslie Farber, and David V. Sheehan. 1997. “Assessing Psychiatric Impairment in Primary Care with the Sheehan Disability Scale”. The International Journal of Psychiatry in Medicine. SAGE Publications. doi:10.2190/t8em-c8yh-373n-1uwd.
clinicaltrials.govStudy
A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD
2020. "A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04077437.
~21 spots leftby May 2025
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