Clinical TrialHealthy VolunteersMDMAWithdrawn

Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2)

Phase 1, open-label, single-group study (n=150) assessing psychological effects and safety of a single 120 mg MDMA dose (optional 60 mg supplemental) paired with preparatory and integrative therapy sessions in healthy volunteers and therapists in training.

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

Detailed Description

This Phase 1, multi-site study evaluates psychological effects and safety of manualised MDMA-assisted psychotherapy in healthy volunteers while supporting therapist training in MDMA-assisted approaches.

Participants receive a single 120 mg oral dose of MDMA (midomafetamine HCl) with an optional 60 mg supplemental dose 1.5–2 hours later, preceded by a non-drug preparatory session and followed by an integrative session; outcomes include mood, self-compassion, burnout, professional quality of life and related psychological measures.

Study Protocol

Preparation

1 sessions

Dosing

1 sessions

Integration

1 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

MDMA-assisted therapy

experimental

One session of MDMA-assisted therapy with a dose of 120 mg midomafetamine HCl and an optional supplemental 60 mg 1.5–2 hours later.

Interventions

  • MDMA120 mg
    via Oral• single dose

    Optional supplemental 60 mg 1.5–2 hours after initial dose.

  • Compound
    via Other• during session

    Non-directive therapy conducted during the MDMA-assisted therapy session.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Are learning to conduct MDMA-assisted psychotherapy or MDMA research through the MDMA Therapy Training Program
  • Are at least 18 years old
  • Are fluent in speaking and reading the predominantly used or recognized language of the study site
  • Are able to swallow pills
  • Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigator in the event of an emergency or if the participant is unreachable
  • Must agree to inform the investigators within 48 hours if any medical conditions occur or medical procedures are planned
  • If of childbearing potential, must have a negative pregnancy test at study entry and prior to the Experimental Session, and must agree to use adequate birth control through 10 days after the Experimental Session
  • If nursing, must be willing to dispose of breastmilk from dosing through 5 days after each Experimental Session
  • Must not participate in any other interventional clinical trials during the duration of the study
  • Must agree to not operate a vehicle for at least 24 hours after initial drug administration.
  • Must have transportation available after the Experimental Session and through the following day, for traveling back for the Integrative Session.
  • Must commit to medication dosing, therapy, and study procedures
  • Are willing to be contacted via telephone for all necessary telephone contacts.

Exclusion Criteria

  • Exclusion Criteria:
  • Are not able to give adequate informed consent
  • Have uncontrolled hypertension
  • Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] in males and >460 ms in females corrected by Bazett's formula)
  • Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • Have evidence or history of significant medical disorders
  • Have symptomatic liver disease
  • Have history of hyponatremia or hyperthermia
  • Weigh less than 45 kilograms (kg)
  • Are pregnant, or are of childbearing potential and are not practicing an effective means of birth control
  • Have any current problematic patterns of alcohol or other substance use

Study Details

  • Status
    Withdrawn
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment150 participants
  • Timeline
    Start: 2021-01-07
    End: 2025-01-12
  • Compound
    MDMA
  • Topic
    Healthy Volunteers

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