Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Pharmacological Interaction Between Clonidine and Methylenedioxymethamphetamine (MDMA)

Randomized double-blind, placebo-controlled crossover Phase I study (n=16) testing clonidine (150 µg) pre-treatment versus placebo on pharmacodynamics and pharmacokinetics of MDMA (125 mg) in healthy volunteers.

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

Detailed Description

Randomized double-blind, placebo-controlled crossover with four experimental sessions. Clonidine (150 µg) or placebo is given 1 hour before MDMA (125 mg) or placebo to 16 healthy volunteers; subjective and cardiovascular responses and plasma pharmacokinetics are repeatedly assessed.

The study tests whether attenuation of norepinephrine release by clonidine reduces the subjective and physiological effects of MDMA, clarifying the role of noradrenergic signalling in MDMA responses.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Clonidine + MDMA

experimental

Within-subject crossover; four sessions testing clonidine or placebo with MDMA or placebo.

Interventions

  • MDMA125 mg
    via Oral• single dose

    MDMA 125 mg single dose administered ~1 h after clonidine/placebo.

  • Compound150 µg
    via Oral• single dose

    Clonidine 150 µg given 1 h before MDMA or placebo.

  • Placebo
    via Oral• single dose

    Placebo capsules identical to MDMA or clonidine.

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Sufficient understanding of the German language
  • Subjects understand the procedures and the risks associated with the study
  • Participants must be willing to adhere to the protocol and sign the consent form
  • Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  • Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session. Subjects must agree not to smoke tobacco for 1 h before and 4 hours after MDMA administration.
  • Participants must be willing not to drive a traffic vehicle in the evening of the study day.
  • Women of childbearing potential must have a negative pregnancy test at the beginning of the study and must agree to use an effective form of birth control. Pregnancy tests are repeated before each study session.
  • Body mass index: 18-25 kg/m2

Exclusion Criteria

  • Exclusion Criteria:
  • Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (>140/90 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.
  • Current or previous psychotic or affective disorder
  • Psychotic or affective disorder in first-degree relatives
  • Prior illicit drug use (except THC (Tetrahydrocannabinol)-containing products) more than 5 times or any time within the previous 2 months.
  • Pregnant or nursing women.
  • Participation in another clinical trial (currently or within the last 30 days)
  • Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment16 participants
  • Timeline
    Start: 2010-01-07
    End: 2010-01-12
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

Clinical Pharmacology & Toxicology, University Hospital Basel — Basel, Basel, Switzerland

Your Library