Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Study of the Effects of MDMA/Ecstasy on Water Regulation, Sleep, and Cognition.

Placebo-controlled, double-blind, within-subject study (n=12) assessing acute and 24–48 h post-dose effects of a single 1.5 mg/kg oral MDMA dose on sleep, water homeostasis, and cognition in experienced users.

Target Enrollment
12 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, quadruple-blind crossover in experienced MDMA users with two inpatient stays to compare single-dose MDMA (1.5 mg/kg) versus matched placebo and to characterise acute and discontinuation effects up to 48 hours.

Primary outcomes include polysomnography and actigraphy measures of sleep architecture, and markers of water and sodium homeostasis including arginine vasopressin and urine free water excretion; effects of water loading are assessed.

Secondary outcomes examine acute changes in mood, sociability, risk-taking and cognitive tasks, oxidative stress markers, and genetic moderators (serotonin transporter promoter short form).

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

MDMA vs Placebo

experimental

Within-subject, placebo-controlled crossover comparing single-dose MDMA (1.5 mg/kg) and matched placebo across two inpatient stays.

Interventions

  • MDMA1.5 mg/kg
    via Oral• single dose

    Single dose 1.5 mg/kg MDMA; administered during inpatient visits; crossover design; each subject receives MDMA at least once.

  • Placebo
    via Oral• single dose

    Matched placebo.

Participants

Ages
18 – 50
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Healthy men or women aged 18 to 50 years.
  • If female: abstains from heterosexual sex, not of childbearing potential, or reports using an approved contraceptive.
  • Experienced with MDMA.
  • Fluent in English.
  • Willing and able to give written consent.
  • Healthy without medical contraindications to MDMA administration determined by medical history, physical examination, 12-lead EKG, hematology, blood chemistry, and urinalysis.
  • Blood liver transaminase elevations up to 3 times the upper limit of normal.
  • If female: negative pregnancy test at screening and at the beginning of each hospital admission.
  • Negative urine drug test at screening and prior to each potential MDMA administration.

Exclusion Criteria

  • Exclusion Criteria:
  • Current enrollment in a MDMA, alcohol, or other drug treatment program or current legal problems relating to MDMA, alcohol, or other drug use.
  • Participants with a past-history of using only low doses of MDMA.
  • Currently trying to quit MDMA use.
  • Current dependence on any other psychoactive drug (including nicotine).
  • Significant physical or psychiatric illness that might impair safe completion of the study or that might be complicated by the study drugs, including prior seizures (after age 8) or other active neurological disease or clinically significant abnormalities on physical examination or screening laboratory values.
  • Likelihood of needing medications to treat an illness during the study period.
  • Body Mass Index > 30 or < 18.
  • HIV seropositive by self-report.
  • If female: pregnancy or lactation.
  • History of serious adverse event or hypersensitivity to MDMA.
  • Currently taking any medication other than over-the-counter non-steroidal anti-inflammatories, topical medications, inhaled asthma therapy, and over-the-counter non-sedating antihistamines.
  • Male neck size ≥ 17 inches, female neck size ≥ 16 inches.
  • Modified Mallampati class ≥ 3.
  • Recent travel within 3 days to or from a different time zone, other than Mountain Standard Time.
  • Any other medical or psychosocial condition that would preclude useful, safe, or consistent participation.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment12 participants
  • Timeline
    Start: 2010-01-04
    End: 2011-01-02
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

CPMC Addiction & Pharmacology Research Laboratory (APRL) — San Francisco, California, United States

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