MDMA-Assisted Therapy for Mental Healthcare Providers

Rachel Yehuda

Status and phase

Enrolling

Phase 1

Conditions

Mental Wellbeing

Treatments

Drug: MDMA Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT07102576

STUDY-24-00412

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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