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No Longer Available No phase listed Expanded access

A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD

ClinicalTrials.gov ID: NCT04438512

Public ClinicalTrials.gov record NCT04438512. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 12:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Intermediate-size Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this expanded access protocol is to provide access to MDMA-assisted therapy for eligible patients with treatment-resistant PTSD who are not able to enroll in another MDMA-assisted therapy clinical trial. Participants will undergo three non-drug preparatory therapy sessions followed by three MDMA-assisted therapy sessions. Each MDMA-assisted therapy session will be followed by three non-drug integrative therapy sessions.

Study identification

NCT ID
NCT04438512
Recruitment status
No Longer Available
Study type
Expanded access
Phase
Not listed
Lead sponsor
Resilient Pharmaceuticals
Industry
Enrollment
Not listed

Conditions and interventions

Interventions

Drug · Behavioral

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Not listed
Last update posted
Nov 5, 2024

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Sunstone Medical, PC Rockville Maryland 20850 —
Pearl Psychedelic Institute Waynesville North Carolina 28786 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04438512, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 5, 2024 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04438512 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →