Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Role of Serotonin in Acute and Subacute MDMA Effects

Randomised, double‑blind, crossover study (n=13) administering MDMA (1.5 mg/kg) with and without citalopram (20 mg) in healthy volunteers to assess the role of serotonin in MDMA's emotional effects.

Target Enrollment
13 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double‑blind, crossover (2×2) study in healthy adult volunteers comparing single doses of MDMA (1.5 mg/kg) with placebo; citalopram 20 mg or placebo is co‑administered to attenuate MDMA‑induced serotonin release.

Primary aim is to measure MDMA's emotional and acute/subacute effects and determine how serotonin depletion by citalopram alters those effects; outcomes include subjective emotional measures and physiological safety assessments.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

MDMA

experimental

MDMA condition in 2×2 crossover with citalopram/placebo co‑administration.

Interventions

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

    MDMA 1.5 mg/kg; co‑administered with citalopram 20 mg or placebo per 2×2 crossover.

  • Compound
    via Oral• single dose

    Citalopram 20 mg oral (pretreatment) when assigned; otherwise placebo.

Placebo

inactive

Placebo condition in 2×2 crossover with citalopram/placebo co‑administration.

Interventions

  • Placebo
    via Oral• single dose

    Placebo capsule; co‑administered with citalopram 20 mg or placebo per 2×2 crossover.

  • Compound
    via Oral• single dose

    Citalopram 20 mg oral (pretreatment) when assigned; otherwise placebo.

Participants

Ages
18 – 50
Sexes
Male & Female

Inclusion Criteria

  • Healthy men or women aged 18 to 50 years
  • Experienced with MDMA
  • Willing and able to provide informed consent and comply with study procedures

Exclusion Criteria

  • Significant physical or psychiatric illness that might impair safety or be complicated by study drugs, including prior seizures (after age 8), history of major depression, other active neurological disease, or clinically significant abnormalities on physical examination or screening laboratory values

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment13 participants
  • Timeline
    Start: 2009-01-02
    End: 2011-01-08
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

CPMC Research Institute, St.Luke's Hospital — San Francisco, California, United States

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