MDMA-Assisted Therapy for Mental Healthcare Providers

Recruiting now · Phase 1

Conditions studied: Mental Wellbeing

In brief

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.

Key facts

Study ID

NCT07102576

Run by

Rachel Yehuda

People needed

30

Starts

2026-02-11

Expected to finish

2029-12-21

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)).

You may not qualify if…

• 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 is running

• The Parsons Research Center for Psychedelic Healing — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.