Anorexia Nervosa Restricting TypePhase 2MED1NCT04454684
A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders
A Phase 2 study testing Midomafetamine, Non-directive therapy and Therapy in people with Anorexia Nervosa Restricting Type and Binge-Eating Disorder, run by Resilient Pharmaceuticals.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Anorexia Nervosa Restricting Type, Binge-Eating Disorder
- What is being tested?
- Midomafetamine, Non-directive therapy and Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to 10 Aug 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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
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- 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
- 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.
About this study
Official title: An Open-Label, Multi-Site Phase 2 Study of the Safety and Feasibility of MDMA-Assisted Psychotherapy for Eating Disorders
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.
Read the 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).
- Being tested
- Midomafetamine, Non-directive therapy, Therapy
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidomafetamineDrug
Also called 3,4-methylenedioxymethamphetamine, MDMA, midomafetamine HCl
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.
Non-directive therapyBehavioural
Also called Manualized MDMA-assisted therapy
Non-directive therapy will be conducted during Experimental Sessions.
TherapyBehavioural
Therapy will be conducted during Preparatory Sessions and Integrative Sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Midomafetamine; Behavioral: Non-directive therapy; Behavioral: Therapy |
| Caregivers: Psychotherapy | Experimental | Psychotherapy alone Receives: Behavioral: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 17 weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study startFeb 2026 (estimated)
- Primary completion10 Aug 2028 (estimated)
- Study completion10 Aug 2028 (estimated)
Why it stopped: No site was initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anorexia Nervosa Restricting TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Examining safety and effects of three sessions of MDMA-assisted psychotherapy
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adele Lafrance, PhD, Principal investigator, Emotion Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454684
- Sponsor's protocol ID
- MED1
- Acronym
- MED1
- Status last verified
- Oct 2024
- First submitted
- 26 Jun 2020
- Last updated
- 31 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share outcome data appearing in any published reports upon request.
Publications
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.
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.
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.
PubMed 20186717
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Site Phase 2 Study of the Safety and Feasibility of MDMA-Assisted Psychotherapy for Eating Disorders
- ClinicalTrials.gov ID
- NCT04454684
- Acronym / sponsor ID
- MED1 / MED1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No site was initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- 10 Aug 2028 (estimated)
- Study completion
- 10 Aug 2028 (estimated)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Examining safety and effects of three sessions of MDMA-assisted psychotherapy
| Arm | Type | Receives |
|---|---|---|
| AN-R: MDMA-assisted Psychotherapy | Experimental | Drug: Midomafetamine, Behavioral: Non-directive therapy, Behavioral: TherapyThree 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 | Experimental | Drug: Midomafetamine, Behavioral: Non-directive therapy, Behavioral: TherapyThree 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 | Experimental | Behavioral: TherapyPsychotherapy alone |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidomafetamineAlso: 3,4-methylenedioxymethamphetamine, MDMA, midomafetamine HClInitial 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. | Drug | AN-R: MDMA-assisted Psychotherapy, BED: MDMA-assisted Psychotherapy |
| Non-directive therapyAlso: Manualized MDMA-assisted therapyNon-directive therapy will be conducted during Experimental Sessions. | Behavioural | AN-R: MDMA-assisted Psychotherapy, BED: MDMA-assisted Psychotherapy |
| TherapyTherapy will be conducted during Preparatory Sessions and Integrative Sessions. | Behavioural | AN-R: MDMA-assisted Psychotherapy, BED: MDMA-assisted Psychotherapy, Caregivers: Psychotherapy |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- BackgroundCooper, 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.
- BackgroundFairburn, 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: PubMed 20186717Keel 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.
- Individual participant dataSharing planned: Yes. We will share outcome data appearing in any published reports upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adele Lafrance, PhD principal investigator
Emotion Science
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Midomafetamine, Non-directive therapy and Therapy in people with Anorexia Nervosa Restricting Type and Binge-Eating Disorder, run by Resilient Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Eating Disorder Examination Interview (EDE) Global Score from Baseline to Visit 16 (Study Termination) (time frame: Baseline to 17 weeks post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04454684, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.