MDMA-Assisted Therapy for Mental Healthcare Providers

ConditionMental Wellbeing

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorRachel Yehuda

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Open-LabelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

At baseline and 28 days post-treatment

Secondary outcomes

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

The MBI-HSS is a 22-item survey scored from 0-6 per item, producing a total score range of 0-132, where higher scores indicate poorer health outcomes. This 22-item survey addresses 3 scales: Emotional Exhaustion: 0-42, which measures feelings of being emotionally overextended and exhausted by one's work; Depersonalization: 0-42, which measures an unfeeling and impersonal response toward recipients of one's service, care treatment, or instruction; and Personal Accomplishment: 0-48, which measures feelings of competence and successful achievement in one's work.

Time frame

At baseline and 28 days post-treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rachel Yehuda

Lead sponsor

Icahn School of Medicine at Mount Sinai

Sponsor institution

Source ClinicalTrials.gov

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