A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders — MED1  

Binge-Eating Disorder Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

This Phase 2, open-label, multi-site study will explore the safety and feasibility of 3,4-methylenedioxymethamphetamine (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 Preparatory Sessions, Experimental Sessions of MDMA-assisted psychotherapy, as well as Individual and Dyadic Integrative Sessions.

A flexible dose of MDMA will be given during Experimental Sessions, ranging from 80 to 120 mg with a supplemental half-dose of 40 or 60 mg 1.5 to 2 hours later, respectively, unless contraindicated. The primary outcome measure is the change in Eating Disorder Examination (EDE) results from Baseline to Visit 16 (Study Termination).

Clinical Trial Description

Both anorexia nervosa and binge eating disorder are associated with a variety of physical and mental health conditions, including anxiety and depression, as well as lower health-related quality of life. Remission rates for eating disorders vary widely from 27 to 85% and existing treatments are relatively ineffective. It is widely accepted that deficits with emotion processing are central to the developmental and maintenance of eating disorder symptoms.

3,4-methylenedioxymethamphetamine (MDMA) is a monoamine releaser and re-uptake inhibitor with indirect effects of neurohormone release. MDMA produces anxiolytic and prosocial effects while slowing identification of negative emotions, increasing acceptance of self and others, and increasing ability to address emotionally upsetting topics. Thus, MDMA has theoretical promise as a treatment for emotional processing, including dysregulation and poor self-esteem, among people with eating disorders and may create a desirable psychological state to enhance the therapeutic process.

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 of MDMA, 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 MDMA, 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). ;

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Anorexia Nervosa Restricting Type
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

• NCT number: NCT04454684
• Study type: Interventional
• Source: Lykos Therapeutics
• Contact: Recruitment Officer
• Phone: 804-513-4687
• Email: recruitment@mapsbcorp.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 2026
• Completion date: August 10, 2028