Clinical TrialHealthy VolunteersMDMARecruiting

MDMA-Assisted Therapy for Mental Healthcare Providers

This Phase I, open-label trial (n=30) will study the psychological and biological effects of MDMA-assisted therapy in mental health providers in training, with a single experimental MDMA session (120 mg initial oral dose with optional 40 mg supplemental dose 1.5–2 hours later), plus preparatory and integration sessions.

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Target Enrollment
30 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Phase I open-label study to evaluate psychological, biological and safety outcomes following one MDMA-assisted therapy session in mental healthcare providers or trainees learning to conduct MDMA-AT.

Participants receive one preparatory session, a single experimental MDMA session (120 mg oral MDMA HCl with an optional 40 mg supplemental dose 1.5–2 hours later), and an integration session the following day; outcomes include mental wellbeing, provider burnout, self-efficacy, mood, psychological flexibility, and quality of life assessed up to one month.

Study Protocol

Preparation

1 sessions

Dosing

1 sessions

Integration

1 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

MDMA-AT

experimental

One-session MDMA-assisted therapy with preparatory and next-day integration session.

Interventions

  • MDMA120 mg
    via Oral• single dose• 2 doses total

    Initial 120 mg oral MDMA HCl followed 1.5–2 hours later by supplemental 40 mg if tolerated; supplemental dose may be withheld or declined.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion 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

  • 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 Protocol, Arms & Participants

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Study Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment30 participants
  • Timeline
    Start: 2025-09-22
    End: 2025-12-21
  • Compound
    MDMA
  • Topic
    Healthy Volunteers

Locations

The Parsons Research Center for Psychedelic Healing — New York, New York, United States

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