NCT04454684

A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders

An Open-Label, Multi-Site Phase 2 Study of the Safety and Feasibility of MDMA-Assisted Psychotherapy for Eating Disorders

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lykos Therapeutics · Industry
• Sex: Female
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy and caregiver involvement are safe and effective in treating female participants with eating disorders. The main question it aims to answer is: Does MDMA-assisted therapy reduce eating disorder symptoms? Participants will undergo two non-drug preparatory therapy sessions and their caregiver will undergo one non-drug preparatory therapy session. Participants will undergo three sessions of MDMA-assisted therapy followed by non-drug integrative therapy sessions alone as well as together with their caregiver.

Detailed description

This Phase 2, open-label, multi-site study will explore the safety and feasibility MDMA-assisted psychotherapy and adjunctive caregiver involvement in the treatment of 18 participants with eating disorders. The study will enroll 12 participants with anorexia nervosa restricting-type (AN-R) and six participants with binge eating disorder (BED). A supportive caregiver, such as a parent or partner, for each participant will also be recruited to participate in the study and receive non-drug psychotherapy support. The study will consist of two Preparatory Sessions for each participant with an eating disorder and one Preparatory Session for each caregiver participant. During the treatment period, participants with eating disorders will undergo three Experimental Sessions of MDMA-assisted psychotherapy, lasting approximately eight hours each. The first Experimental Session will be followed by Individual Integrative Sessions for the participant with an eating disorder and caregiver participant separately as well as a combined Dyadic Integrative Session with both the participant with an eating disorder and their caregiver together. After the second and third Experimental Session, just the participant with an eating disorder will have an Individual Integrative Session before the combined Dyadic Integrative Session with their caregiver. The first Experimental Session will involve a dose of 80 mg midomafetamine HCl, followed by a supplemental half-dose of 40 mg 1.5 to 2 hours later, unless contraindicated. The second and third Experimental Sessions will involve a flexible dose of 80 or 120 mg of midomafetamine HCl, followed by a supplement half-dose of 40 or 60 mg, respectively, unless contraindicated. The primary outcome measure is the change in Eating Disorder Examination (EDE) results at Baseline to Visit 16 (Study Termination).

Conditions

• Anorexia Nervosa Restricting Type
• Binge-Eating Disorder

Interventions

Type	Name	Description
DRUG	Midomafetamine	Initial dose of 80 or 120 mg midomafetamine HCl administered orally at the start of each of three psychotherapy sessions, followed by a supplemental half-dose of 40 to 60 mg midomafetamine HCl 1.5 to 2.5 hours later, unless contraindicated.
BEHAVIORAL	Non-directive therapy	Non-directive therapy will be conducted during Experimental Sessions.
BEHAVIORAL	Therapy	Therapy will be conducted during Preparatory Sessions and Integrative Sessions.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-08-10
• Completion: 2028-08-10
• First posted: 2020-07-01
• Last updated: 2024-10-31

Regulatory

• FDA-regulated drug study