Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

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

This study will compare the effects of methylenedioxymethamphetamine (MDMA) and placebo on mood and psychological experience in people trained to practice MDMA-assisted psychotherapy in a therapy-like setting.

Target Enrollment
107 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

Randomized, double-blind, triple-masked, crossover Phase 1 study in healthy volunteers trained in MDMA-assisted psychotherapy (actual n=107). Each participant receives one MDMA session (120 mg oral, supplemental 40 mg optional 1.5–2.5 h later) and one lactose placebo session in random order with at least two days between sessions.

Each experimental session is preceded by a non-drug preparatory session and followed by an integrative session. Outcomes include mood, interpersonal closeness, psychological symptoms, blood pressure, heart rate, body temperature, and personality measures with telephone follow-up at 1 and 2 months.

Study Protocol

Preparation

2 sessions

Dosing

2 sessions

Integration

2 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

MDMA

experimental

Active MDMA session in crossover (may include supplemental dose).

Interventions

  • MDMA120 - 160 mg
    via Oral• single dose

    120 mg initial oral MDMA; supplemental 40 mg may be given 1.5–2.5 hours later; sessions in crossover design.

Placebo

inactive

Lactose inactive placebo matching capsules in crossover.

Interventions

  • Placebo
    via Oral• single dose

    Lactose inactive placebo matching MDMA capsules; equivalent initial and supplemental doses.

Participants

Ages
21 – 99
Sexes
Male & Female

Inclusion Criteria

  • Engaged in a sponsor-supported program for training therapists to perform MDMA-assisted psychotherapy research
  • Are at least 21 years old
  • Are willing to follow all rules and restrictions related to study participation, including restrictions on medication use for a week prior to experimental sessions and restrictions on food and alcohol consumption on the day prior to each experimental session
  • Are willing to remain overnight at the study site
  • Agree to have transportation other than driving themselves after the integrative session on the day after each experimental session
  • Are willing to be contacted via telephone for all necessary telephone contacts
  • If a woman of childbearing potential, must have a negative pregnancy test and agree to use an effective form of birth control
  • Are proficient in speaking and reading English
  • Agree to have all clinic visit sessions recorded to audio and video

Exclusion Criteria

  • Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control
  • Weigh less than 48 kg
  • Have used "ecstasy" (material represented as containing MDMA) within 6 months of the MDMA session
  • Require ongoing therapy with a psychotropic drug
  • Meet DSM-V criteria for substance abuse or dependence for any substance
  • Unable to give adequate informed consent
  • Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary
  • Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment107 participants
  • Timeline
    Start: 2011-01-10
    End: 2021-01-06
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

Aguazul Bluewater, Inc. — Boulder, Colorado, United States
Santa Fe MDMA Therapy Training, LLC — Santa Fe, New Mexico, United States
Zen Therapeutic Solutions — Mt. Pleasant, South Carolina, United States

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