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

NCT04454684 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: MED1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anorexia Nervosa Restricting Type; Binge-Eating Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Eating Disorder Examination Interview (EDE) Global Score from Baseline to Visit 16 (Study Termination)

  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.

  Baseline to 17 weeks post-enrollment

Study Arms (3)

AN-R: MDMA-assisted Psychotherapy

EXPERIMENTAL

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.

Drug: Midomafetamine; Behavioral: Non-directive therapy; Behavioral: Therapy

BED: MDMA-assisted Psychotherapy

EXPERIMENTAL

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.

Drug: Midomafetamine; Behavioral: Non-directive therapy; Behavioral: Therapy

Caregivers: Psychotherapy

EXPERIMENTAL

Psychotherapy alone

Behavioral: Therapy

Interventions

Midomafetamine DRUG

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.

Also known as: 3,4-methylenedioxymethamphetamine, MDMA, midomafetamine HCl

AN-R: MDMA-assisted Psychotherapy; BED: MDMA-assisted Psychotherapy

Non-directive therapy BEHAVIORAL

Non-directive therapy will be conducted during Experimental Sessions.

Also known as: Manualized MDMA-assisted therapy

AN-R: MDMA-assisted Psychotherapy; BED: MDMA-assisted Psychotherapy

Therapy BEHAVIORAL

Therapy will be conducted during Preparatory Sessions and Integrative Sessions.

AN-R: MDMA-assisted Psychotherapy; BED: MDMA-assisted Psychotherapy; Caregivers: Psychotherapy

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Assigned female at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are 21 to 65 years old.
• Are assigned female at birth.
• Are fluent in speaking and reading the English language and can provide written informed consent.
• Are able to swallow pills.
• Agree to have study visits recorded to audio and video.
• Are willing to include a consenting caregiver as a co-participant in elements of the study with whom the study team will have regular contact. This person must be willing and able to be reached by the investigators in case of emergency.
• If connected to a psychotherapist at the time of recruitment into the study, participants may not change therapists, change the frequency of therapy, or commence any new type of therapy until after the Study Termination Visit, 1 month after the final Experimental Session.
• Have an identified Primary Care Physician (PCP) and provide consent for the investigator to communicate with PCP, as needed.
• If AN-R diagnosis, are currently participating in a recognized ED treatment program.
• Are willing to sign a release for the investigators to communicate directly with their therapist, physician if relevant, as well treatment providers where they were currently or previously engaged an ED-specific episode of treatment.
• Live within reasonable driving distance of the study site (equal to or less than an estimated 2-hour drive from the study site).
• If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control
• Agree to inform the investigators within 48 hours of any medical conditions and procedures.
• Agree to lifestyle modifications, comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, remain overnight at the study site (or appropriate location approved by the research team) after each Experimental Session, not operate a vehicle within 24 hours after MDMA administration, and commit to medication dosing, therapy, and study procedures.
• Have Anorexia Nervosa, Restricting Type or Binge Eating Disorder.

You may not qualify if:

• Are not able to give adequate informed consent.
• Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation.
• Cannot identify a supportive caregiver to participate in the study (or the caregiver does not meet eligibility criteria).
• Have a blood or needle phobia that interferes with obtaining necessary blood work
• Have a history of significant medical disorders
• Have any current problematic patterns of alcohol or other substance use
• Require use of prohibited concomitant medications for this study, including those that prolong the QT/QTc interval during Experimental Sessions.
• Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate.
• Have uncontrolled hypertension or history of ventricular arrhythmia.
• Have Wolff-Parkinson-White syndrome or any other accessory pathway.
• Have a marked Baseline prolongation of QTcF interval (e.g., repeated demonstration of a QTcF interval \> 450 ms).
• Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
• Have symptomatic liver disease.
• Have a history of non-ED-symptom-related hyponatremia or hyperthermia.
• Are pregnant or nursing, or are persons of childbearing potential who are not practicing (or not willing to practice) an effective means of birth control.

Sponsors & Collaborators

• Lykos Therapeutics: lead

Related Publications (3)

• Cooper, Z. and C. Fairburn, The eating disorder examination: A semi-structured interview for the assessment of the specific psychopathology of eating disorders. International journal of eating disorders, 1987. 6(1): p. 1-8.

  BACKGROUND

• Fairburn, C., Z. Cooper, and M. O'Connor, Eating Disorder Examination (Edition 17.0D; April, 2014). 2014: https://www.corc.uk.net/media/1951/ede_170d.pdf.

  BACKGROUND

• Keel PK, Brown TA. Update on course and outcome in eating disorders. Int J Eat Disord. 2010 Apr;43(3):195-204. doi: 10.1002/eat.20810.

  PMID: 20186717 BACKGROUND

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Therapeutics

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Adele Lafrance, PhD

  Emotion Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This study will be open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Examining safety and effects of three sessions of MDMA-assisted psychotherapy

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 1, 2020
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 10, 2028
• Study Completion (Estimated): August 10, 2028
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data and study-related documents will be available wehn all participants have completed the study.
• Access Criteria: Interested persons should correspond with the central contact for the multi-site study.