MDMA-Assisted Therapy for Mental Healthcare Providers

NCT ID: NCT07102576

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2029-12-21

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.

Detailed Description

This study is investigating the psychological and biological effects and safety of MDMA-assisted therapy (MDMA-AT) in healthy volunteers who are: 1) mental healthcare providers or trainees, and 2) learning or have been certified to conduct MDMA-AT. As research in MDMA-AT expands, there is a need to evaluate the safety and efficacy of MDMA-assisted therapy in healthy volunteers, in order to better understand its effects in populations beyond clinical samples and to inform future comparisons. This study will assess whether a relatively brief intervention (consisting of one MDMA-AT session with one preparatory and one integration session) can improve overall mental wellbeing in a healthy sample of mental healthcare providers, while also evaluating its effects on provider burnout, self-assessed counselor efficacy, mood, psychological flexibility, quality of life, and experiential avoidance. In addition, this study supports continued training for new MDMA-AT providers, including the option for their own MDMA experience to expand on their knowledge of the subjective effects and therapeutic potential of MDMA-AT and enhance their qualifications to provide that therapy. Participants will engage in structured preparation, treatment, and follow-up, guided by trained clinical professionals. Assessments will take place throughout the study to monitor mental health outcomes and ensure participant well-being. Participation will consist of: - Screening Period (up to 4 weeks): Phone screen, informed consent, eligibility assessment, and enrollment. - Preparatory Period (1-4 weeks): Preparatory session with study clinicians, baseline assessments. - Treatment Period (2 days): Experimental session (MDMA administered in a controlled therapeutic setting) followed by an integrative session the next day. - Follow-Up Period (up to 4 weeks): Follow-up visit approximately one month after experimental session, outcome assessments, and study termination.

Conditions

Mental Wellbeing

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Open-Label

One session of MDMA-Assisted Therapy

Group Type: EXPERIMENTAL

MDMA Hydrochloride

Intervention Type: 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.

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rachel Yehuda

OTHER

Sponsor Role: lead

Responsible Party

Rachel Yehuda

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tamar Glatman Zaretsky

Role: STUDY_DIRECTOR

Mount Sinai Icahn School of Medicine

Rachel Yehuda

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Icahn School of Medicine

Locations

The Parsons Research Center for Psychedelic Healing

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lily Fischer

Role: CONTACT

Phone: 862-253-1938

Email: lily.fischer@mssm.edu

Jean Mendez

Role: CONTACT

Email: jean.mendez@mssm.edu

Facility Contacts

Tamar Glatman Zaretsky, PsyD

Role: primary

Lily Fischer, MSc

Role: backup

Other Identifiers

STUDY-24-00412

Identifier Type: -

Identifier Source: org_study_id