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

NCT04438512 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2024-11-05

No results posted yet for this study

Summary

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.

Conditions

  • Post Traumatic Stress Disorder

Interventions

DRUG

Midomafetamine

Administration of 80 or 120 mg midomafetamine HCl in combination with manualized therapy and a supplemental dose 1.5 to 2 hrs later of 40 or 60 mg midomafetamine HCl, respectively

BEHAVIORAL

Psychotherapy

Manualized therapy performed by therapist team

Sponsors & Collaborators

Principal Investigators

  • Manish Agrawal, MD · Sunstone Medical, PC

  • Caroline Lewis, MD · Pearl Psychedelic Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04438512 on ClinicalTrials.gov