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MDMA-Assisted Therapy for Mental Healthcare Providers
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
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full 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
About the study
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.
What is being tested
- MDMA Hydrochloride (drug)
Sponsor: Rachel Yehuda · Participants: 30 · Started: Feb 11, 2026
Contact the study team
- Lily Fischer · Phone: 862-253-1938
Official record on ClinicalTrials.gov — NCT07102576
Locations in the U.S.
| New York | The Parsons Research Center for Psychedelic Healing, New York |
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.