Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Evaluation of MDMA on Startle Response

Randomized, double-blind, placebo-controlled Phase I study (n=34) evaluating the effect of a single 100 mg MDMA dose versus inactive placebo on acoustic startle response in healthy volunteers.

Target Enrollment
34 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

Randomized, double-blind, parallel-group Phase I trial in healthy volunteers comparing a single oral 100 mg MDMA dose to inactive placebo; acoustic startle testing occurs at baseline, after dosing (Visit 2) and at a follow-up (Visit 3).

Outcomes include startle magnitude (orbicularis oculi EMG), vitals and repeated blood sampling for oxytocin and exploratory biomarkers; sleep is tracked by self-report and Fitbit, and participants complete experience questionnaires.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

100 mg MDMA

experimental

Single 100 mg MDMA HCl administered at Visit 2 with acoustic startle assessment.

Interventions

  • MDMA100 mg
    via Oral• single dose• 1 doses total
  • Compound
    via Other• single session

    Acoustic startle assessment (behavioral)

Placebo

inactive

Inactive lactose placebo administered at Visit 2 with acoustic startle assessment.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Inactive lactose placebo

  • Compound
    via Other• single session

    Acoustic startle assessment (behavioral)

Participants

Ages
21 – 55
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Persons aged 21 to 55.
  • Ability to visually read and understand English language.
  • Live within in metro Atlanta area
  • Previously used MDMA in a recreational or research setting
  • If a person is of childbearing potential (able to bear children), they must have a negative pregnancy test at study entry and prior to the Experimental Session. They must agree to use adequate birth control through 10 days after the last dose of MDMA. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Not of childbearing potential is defined as permanent sterilization, postmenopausal, or male.
  • (For sub-study measuring serum oxytocin) Willing to have periodic blood draws

Exclusion Criteria

  • Exclusion Criteria:
  • Upon review of medical or psychiatric history, have any current or past diagnosis that would be considered a risk to participating in the study.
  • Are abusing illegal drugs.
  • Current use of any psychoactive medications, including antidepressants, mood stabilizers, sedatives, stimulants, antipsychotics, anxiolytics, or beta-blockers
  • Are not able to give adequate informed consent.
  • Uncontrolled hypertension, or clinically significant cardiac arrhythmia, as detected by electrocardiogram.
  • Currently pregnant or breast-feeding.
  • History of acute angle glaucoma.
  • Hearing impairment as assessed by audiometer; unable to detect tones below 40 dB in right or left ear.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment34 participants
  • Timeline
    Start: 2017-09-21
    End: 2020-11-04
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

Emory University — Atlanta, Georgia, United States

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