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

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ClinicalTrials.gov Identifier: NCT04454684
Recruitment Status : Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Tracking Information
First Submitted Date  ICMJE June 26, 2020
First Posted Date  ICMJE July 1, 2020
Last Update Posted Date October 8, 2021
Estimated Study Start Date  ICMJE December 2021
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
Change in Eating Disorder Examination Interview (EDE) Global Score from Baseline to Visit 16 (Study Termination) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
Change from Baseline in Eating Disorder Examination (EDE) [ Time Frame: 17 weeks post-enrollment ]
The 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 with subscale scores for Restraint, Eating Concern, Shape Concern, and Weight Concern. Behavioral symptoms such as binge eating, self-induced vomiting, and excessive exercise
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
Change from Baseline in Readiness and Motivation Questionnaire (RMQ) [ Time Frame: 17 weeks post-enrollment ]
The RMQ is a self-report measure intended to assess readiness for change among individuals with eating disorders as conceptualized according to the Transtheoretical Model of Change. For each eating disorder symptom of the EDE, the RMQ asks individuals to provide ratings for precontemplation, action/maintenance, and internality. The RMQ does not provide a contemplation rating, but does include a confidence rating to assess perceived self-efficacy for change. Symptoms are grouped into restriction, cognitive, compensatory, and bingeing domains.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders
Official Title  ICMJE An Open-Label, Multi-Site Phase 2 Study of the Safety and Feasibility of MDMA-Assisted Psychotherapy for Eating Disorders
Brief 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).

Detailed 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Examining safety and effects of three sessions of MDMA-assisted psychotherapy
Masking: None (Open Label)
Masking Description:
This study will be open label
Primary Purpose: Treatment
Condition  ICMJE
  • Anorexia Nervosa Restricting Type
  • Binge-Eating Disorder
Intervention  ICMJE
  • Drug: MDMA
    Initial dose of 80 or 120 mg MDMA administered orally at the start of each of three psychotherapy sessions, followed by a supplemental half-dose of 40 to 60 mg MDMA 1.5 to 2.5 hours later, unless contraindicated.
    Other Name: 3,4-methylenedioxymethamphetamine
  • Behavioral: Non-directive Psychotherapy
    Non-directive psychotherapy will be conducted during Experimental Sessions.
    Other Name: Manualized MDMA-assisted psychotherapy
  • Behavioral: Psychotherapy
    Psychotherapy will be conducted during Preparatory Sessions and Integrative Sessions.
Study Arms  ICMJE
  • Experimental: AN-R: MDMA-assisted Psychotherapy
    Three Experimental Sessions of MDMA-assisted psychotherapy. The first Experimental Session involves 80mg MDMA followed by a supplemental half-dose of 40 mg MDMA 1.5 to 2 hours later, unless contraindicated. The second and third Experimental Sessions involve a flexible dose of 80 or 120 mg of MDMA followed by a supplemental half-dose of 40 or 80 mg MDMA, respectively, 1.5 to 2 hours later, unless contraindicated.
    Interventions:
    • Drug: MDMA
    • Behavioral: Non-directive Psychotherapy
    • Behavioral: Psychotherapy
  • Experimental: BED: MDMA-assisted Psychotherapy
    Three Experimental Sessions of MDMA-assisted psychotherapy. The first Experimental Session involves 80mg MDMA followed by a supplemental half-dose of 40 mg MDMA 1.5 to 2 hours later, unless contraindicated. The second and third Experimental Sessions involve a flexible dose of 80 or 120 mg of MDMA followed by a supplemental half-dose of 40 or 80 mg MDMA, respectively, 1.5 to 2 hours later, unless contraindicated.
    Interventions:
    • Drug: MDMA
    • Behavioral: Non-directive Psychotherapy
    • Behavioral: Psychotherapy
  • Experimental: Caregivers: Psychotherapy
    Psychotherapy alone
    Intervention: Behavioral: Psychotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2020)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for Eating Disorder (ED) Participants:

  • 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.
  • Current or past treatment were not successful to retain remission
  • Have a BMI > 15 kg/m2 and are medically stable according to screening Electrocardiogram (ECG), blood pressure monitoring, and blood and urine laboratory screening results.

Exclusion Criteria for Eating Disorder (ED) Participants:

  • 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.
  • Are assessed to be medically unstable

Inclusion Criteria for Caregiver (CG) Participants:

  • Are fluent in speaking and reading the English language and can provide written informed consent.
  • Are at least 18 years old.
  • Are the parent, partner, or other significant caregiver of the ED Participant.
  • Are involved in caregiving at least 2 hours a week (i.e. companionship, meal support, emotional support, driving to appointments, financial support, etc.).
  • Are willing to provide their loved one with meal/symptom support and emotional support throughout the study.
  • Live within reasonable driving distance of the study site
  • If in ongoing psychotherapy at the time participants are recruited into the study, caregiver participants may continue to see their outside therapist during the course of the study. Caregiver participants must sign a release for the investigators to communicate directly with their therapist. CG Participants may not change therapists, increase the frequency of therapy, or commence any new type of therapy until after their Study Termination Visit.
  • Are willing to commit to Preparatory and Integrative Sessions, completion of evaluation instruments and other study procedures, and being contacted for all necessary telephone contacts.
  • Agree to have study visits recorded to audio and video.

Exclusion Criteria for Caregiver (CG) Participants:

  • Have a current eating disorder.
  • Are unable to give adequate informed consent.
  • Report any current problem which in the opinion of the investigator or Medical Monitor might interfere with enrollment or ongoing participation.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Assigned female at birth
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruitment Officer (215) 645-2466 recruitment@mapsbcorp.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04454684
Other Study ID Numbers  ICMJE MED1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We will share outcome data appearing in any published reports upon request.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (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.
Responsible Party Multidisciplinary Association for Psychedelic Studies
Study Sponsor  ICMJE Multidisciplinary Association for Psychedelic Studies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Corine de Boer, MD MAPS Public Benefit Corp.
PRS Account Multidisciplinary Association for Psychedelic Studies
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP