NCT04438512

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

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

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Lykos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed description

This is an open-label, expanded access protocol for eligible patients with treatment-resistant PTSD. This protocol is designed to provide access to MDMA-assisted therapy for patients who are not eligible for participation in another ongoing MDMA-assisted therapy clinical trial. In addition, this program will provide supportive data on safety and tolerability of MDMA-assisted therapy in treatment-resistant patients with PTSD. The study will treat up to 50 patients. A flexible dose of MDMA (80 to 120 mg midomafetamine HCl), followed by a supplemental dose unless contraindicated, is administered during the Treatment Period with manualized therapy in up to three open-label Experimental Sessions. During the Treatment Period, each Experimental Session is preceded by three 90-minute Preparatory Sessions and followed by three 90-minute Integrative Sessions of non-drug therapy. Experimental Sessions will be followed by an overnight stay.

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
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

Timeline

• First posted: 2020-06-18
• Last updated: 2024-11-05

Locations

2 sites across 1 country: United States