RecruitingPhase 1MDMA

MDMA-Assisted Therapy for Mental Healthcare Providers

Sponsored by Rachel Yehuda

NCT ID
NCT07102576
Target Enrollment
30 participants
Start Date
2026-01
Est. Completion
2029-12-21

About This 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.

Conditions Studied

Mental Wellbeing

Interventions

  • MDMA Hydrochloride

Eligibility

Age:18 Years - N/A
Healthy Volunteers:Yes
View 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

Study Locations (1)

The Parsons Research Center for Psychedelic Healing
New York, New York, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Jean Mendez
CONTACT
jean.mendez@mssm.edu
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source

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