MDMA-Assisted Therapy for Mental Healthcare Providers

NCT07102576 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: STUDY-24-00412
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mental Health Continuum-Short Form (MHC-SF)

  The MHC-SF is a self-report measure consisting of 14 questions rated for the frequency at which they are experienced, on a scale from "0-never" to "5-every day" within the past month. The MHC-SF is a shortened version of the Mental Health Continuum Long Form (MHC-LF), a 40-item measure which was developed to assess emotional, social, and psychological well-being, a three factor structure validated in national and international populations. The MHC-SF was developed using a subset of items from the MHC-LF to represent each of these three well-being constructs: The MHC-SF yields a total score range of 0-70, where higher scores reflect greater mental well-being. Subscale ranges are: Emotional Well-Being: 0-15 (3 items), Psychological Well-Being: : 0-30 (6 items), and Social Well-Being: 0-25 (5 items). Subscale scores reflect functioning in each domain, while the total score captures overall mental well-being.

  At baseline and 28 days post-treatment

Secondary Outcomes (1)

• The Maslach Burnout Inventory - Human Services Survey (MBI-HSS)

  At baseline and 28 days post-treatment

Study Arms (1)

Open-Label

EXPERIMENTAL

One session of MDMA-Assisted Therapy

Drug: MDMA Hydrochloride

Interventions

MDMA Hydrochloride DRUG

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.

Open-Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rachel Yehuda: lead

Study Sites (1)

The Parsons Research Center for Psychedelic Healing

New York, New York, 10025, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Tamar Glatman Zaretsky

  Mount Sinai Icahn School of Medicine

  STUDY DIRECTOR

• Rachel Yehuda

  Mount Sinai Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lily Fischer

CONTACT

862-253-1938; therapistwellbeing@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 3, 2025
• Study Start: February 11, 2026
• Primary Completion (Estimated): September 21, 2029
• Study Completion (Estimated): December 21, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)