MDMA-assisted therapy for mental healthcare providers in training
Official title: A Phase 1, Open-Label Study to Assess Psychological and Biological Effects of MDMA Assisted Therapy When Administered to Mental Health Providers in Training to be MDMA-Assisted Therapists
Run by Icahn School of Medicine at Mount Sinai · NCT07102576 · Data updated 2026-11-12
This study will try a single MDMA-assisted therapy session (with one prep and one integration visit) in mental healthcare providers training to deliver MDMA therapy to see if it improves overall mental wellbeing and reduces burnout.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | February 11, 2026 |
| Main results expected | September 21, 2029 |
| Study ends | December 21, 2029 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07102576 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Licensed, license-eligible, or trainee mental health professionals who are enrolled in or certified by the Lykos MDMA‑Assisted Therapy Training program, are at least 18 years old, fluent in English, weigh at least 45 kg, can swallow pills, can provide a local support contact, and consent to audiovisual recording.
✕Probably not a fit
People who are not mental healthcare providers or not enrolled in the specified training, or those with recent changes in psychiatric care, current substance use disorders, or other medical/psychiatric exclusion criteria are unlikely to qualify or benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, open-label study delivering one MDMA-assisted therapy session with a preparatory visit and a next-day integration visit to mental healthcare providers who are learning or certified to provide MDMA-AT. Participants work with a co-therapy pair while clinicians collect repeated measures of mental wellbeing, burnout, self-efficacy, mood, self-compassion, quality of life, and other psychological factors. Safety and psychological responses will be monitored throughout the protocol, with audiovisual recording of sessions and follow-up assessments. The goal is to characterize psychological and biological effects in healthy provider volunteers and to inform future comparisons and training practices.
Why it matters
Potential benefit: If successful, this approach could improve mental wellbeing and lower burnout among mental health providers while informing training for future MDMA-assisted therapists.
How similar studies have gone: MDMA-assisted therapy has shown positive results in clinical PTSD trials, but applying a single-session MDMA experience to healthy provider trainees for wellbeing and training purposes is relatively novel and less studied.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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The Parsons Research Center for Psychedelic Healing
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Rachel Yehuda — Mount Sinai Icahn School of Medicine
- Study coordinator: Lily Fischer
- Email: therapistwellbeing@mssm.edu
- Phone: 862-253-1938
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.