A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders
- Conditions
- Anorexia Nervosa Restricting TypeBinge-Eating Disorder
- Interventions
- Registration Number
- NCT04454684
- Lead Sponsor
- Lykos Therapeutics
- Brief 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).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AN-R: MDMA-assisted Psychotherapy Midomafetamine Three Experimental Sessions of MDMA-assisted psychotherapy. The first Experimental Session involves 80mg midomafetamine HCl followed by a supplemental half-dose of 40 mg midomafetamine HCl 1.5 to 2 hours later, unless contraindicated. The second and third Experimental Sessions involve a flexible dose of 80 or 120 mg midomafetamine HCl followed by a supplemental half-dose of 40 or 80 mg midomafetamine HCl, respectively, 1.5 to 2 hours later, unless contraindicated. BED: MDMA-assisted Psychotherapy Midomafetamine Three Experimental Sessions of MDMA-assisted psychotherapy. The first Experimental Session involves 80mg midomafetamine HCl followed by a supplemental half-dose of 40 mg midomafetamine HCl 1.5 to 2 hours later, unless contraindicated. The second and third Experimental Sessions involve a flexible dose of 80 or 120 mg of midomafetamine HCl followed by a supplemental half-dose of 40 or 80 mg midomafetamine HCl, respectively, 1.5 to 2 hours later, unless contraindicated. AN-R: MDMA-assisted Psychotherapy Non-directive therapy Three Experimental Sessions of MDMA-assisted psychotherapy. The first Experimental Session involves 80mg midomafetamine HCl followed by a supplemental half-dose of 40 mg midomafetamine HCl 1.5 to 2 hours later, unless contraindicated. The second and third Experimental Sessions involve a flexible dose of 80 or 120 mg midomafetamine HCl followed by a supplemental half-dose of 40 or 80 mg midomafetamine HCl, respectively, 1.5 to 2 hours later, unless contraindicated. AN-R: MDMA-assisted Psychotherapy Therapy Three Experimental Sessions of MDMA-assisted psychotherapy. The first Experimental Session involves 80mg midomafetamine HCl followed by a supplemental half-dose of 40 mg midomafetamine HCl 1.5 to 2 hours later, unless contraindicated. The second and third Experimental Sessions involve a flexible dose of 80 or 120 mg midomafetamine HCl followed by a supplemental half-dose of 40 or 80 mg midomafetamine HCl, respectively, 1.5 to 2 hours later, unless contraindicated. BED: MDMA-assisted Psychotherapy Non-directive therapy Three Experimental Sessions of MDMA-assisted psychotherapy. The first Experimental Session involves 80mg midomafetamine HCl followed by a supplemental half-dose of 40 mg midomafetamine HCl 1.5 to 2 hours later, unless contraindicated. The second and third Experimental Sessions involve a flexible dose of 80 or 120 mg of midomafetamine HCl followed by a supplemental half-dose of 40 or 80 mg midomafetamine HCl, respectively, 1.5 to 2 hours later, unless contraindicated. BED: MDMA-assisted Psychotherapy Therapy Three Experimental Sessions of MDMA-assisted psychotherapy. The first Experimental Session involves 80mg midomafetamine HCl followed by a supplemental half-dose of 40 mg midomafetamine HCl 1.5 to 2 hours later, unless contraindicated. The second and third Experimental Sessions involve a flexible dose of 80 or 120 mg of midomafetamine HCl followed by a supplemental half-dose of 40 or 80 mg midomafetamine HCl, respectively, 1.5 to 2 hours later, unless contraindicated. Caregivers: Psychotherapy Therapy Psychotherapy alone
- Primary Outcome Measures
Name Time Method Change in Eating Disorder Examination Interview (EDE) Global Score from Baseline to Visit 16 (Study Termination) Baseline to 17 weeks post-enrollment The Eating Disorder Examination Interview (EDE) is a semi-structured interview that assesses the frequency of key behavioral features of eating disorders as well as the severity of specific ED psychopathology. The EDE is widely considered to be the gold standard for assessing eating disorder pathology and can detect differences between individuals with anorexia nervosa and binge eating disorder.
The EDE consists of four subscales: Restraint, Eating Concern, Shape Concern, and Weight Concern. The interview rates each question based on its frequency in the past month from a score of 0 (feature not present) to 6 (feature present every day). Subscale scores are calculated by totaling the scores in each subscale and dividing by the total number of items in the subscale. The overall or global score is calculated by summing the four subscale scores and dividing by four. The higher the score, the greater the eating disorder severity and frequency.
- Secondary Outcome Measures
Name Time Method