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
Rachel Yehuda
30 participants
Feb 11, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria12
- 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
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Interventions
Initial dose of 120 mg MDMA HCl in a therapeutic setting, followed 1.5 to 2 hours later by a supplemental dose of 40 mg MDMA HCl. Supplemental doses may be withheld if tolerability issues emerge or it is declined by the participant.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07102576