NCT07102576 MDMA-Assisted Therapy for Mental Healthcare Providers
| NCT ID | NCT07102576 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Rachel Yehuda |
| Condition | Mental Wellbeing |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-02-11 |
| Primary Completion | 2029-09-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-02-11 with a primary completion date of 2029-09-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase 1, open-label study to assess changes in mental well-being following MDMA administration within a therapeutic setting, in mental health providers who are in training to become MDMA assisted therapists. Secondary outcome measures will examine the effects on provider burnout, provider self-efficacy, mood, self-compassion, quality of life, and other psychological factors. Participants will work with a co-therapy pair as they engage in a preparatory session, one experimental session with MDMA, and an integration session the following day.
Eligibility Criteria
Inclusion Criteria: * Are at least 18 years at the time of signing the informed consent. * Fluent in English * Able to swallow pills * Agree to have study visits audiovisually recorded * Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable. * Must be licensed, license-eligible, or trainees in a relevant healthcare/mental health profession * Must be learning or have been certified to conduct MDMA-assisted therapy through the Lykos MDMA-Assisted Therapy Training program or authorized affiliate program * Body weight of at least 45 kilograms (kg; or 100 pounds (lbs)). Exclusion Criteria * Have engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment * Have a current alcohol or cannabis use disorder of any severity within the 12 months prior to enrollment * Have a substance use disorder of any severity within 12 months prior to enrollment * Any suicidal ideation within the last 6 months * Repetitive or recent use of Ecstasy/MDMA * Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician * Meet diagnostic criteria for a Major Depressive Episode currently or within the prior 3 months or meet diagnostic criteria for a current anxiety disorder assessed * Have a current eating disorder with compensatory behaviors * Have a history of, or a current primary psychotic disorder or bipolar disorder * Previous participation in a clinical trial that included administration of MDMA * Individuals in a personal relationship with the site investigator * Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception
Contact & Investigator
Tamar Glatman Zaretsky
STUDY DIRECTOR
Mount Sinai Icahn School of Medicine
Frequently Asked Questions
Who can join the NCT07102576 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mental Wellbeing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07102576 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07102576 currently recruiting?
Yes, NCT07102576 is actively recruiting participants. Contact the research team at therapistwellbeing@mssm.edu for enrollment information.
Where is the NCT07102576 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07102576 clinical trial?
NCT07102576 is sponsored by Rachel Yehuda. The principal investigator is Tamar Glatman Zaretsky at Mount Sinai Icahn School of Medicine. The trial plans to enroll 30 participants.