Recruiting
Phase 1

MDMA

Sponsor:

Rachel Yehuda

Code:

NCT07102576

Conditions

Mental Wellbeing

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

MDMA Hydrochloride

Study Details

Brief 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.

Conditions

Mental Wellbeing

Study ID

NCT07102576

Start date

Feb 11, 2026

Status verified date

Feb, 2026

Completion date

Dec 21, 2029

Anticipated

Primary completion date

Sep 21, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Open-Label

One session of MDMA-Assisted Therapy

Interventions

MDMA Hydrochloride

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.

Primary outcome measure

  • Mental Health Continuum-Short Form (MHC-SF) [ Time Frame: At baseline and 28 days post-treatment ]

Central Contacts and Locations

Central contacts

Lily Fischer

862-253-1938therapistwellbeing@mssm.edu

Locations

The Parsons Research Center for Psychedelic Healing

Recruiting

New York, New York, United States, 10025

Contacts

Tamar Glatman Zaretsky, PsyD

(914) 340-3669tamar.glatmanzaretsky@mssm.edu

Lily Fischer, MSc

‪(862) 253-1938‬therapistwellbeing@mssm.edu

Principal Investigator:

Rachel Yehuda, PhD

More Information

Sponsor

Rachel Yehuda

Last update posted

Mar 27, 2026

Last verified

Feb, 2026

Keywords

  • Psychedelic Therapy
  • MDMA
  • MDMA-Assisted Therapy
  • Mental Health
  • Therapist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rachel Yehuda on 2026-03-27.