Clinical TrialHealthy VolunteersMDMAMDMAPlaceboPlaceboCompleted

Interactions between 3,4-methylenedioxymethamphetamine (MDMA or ’ecstasy’) and Δ9-tetrahydrocannabinol (THC or ‘marihuana’) in humans

Double-blind, randomised, placebo-controlled crossover study (n=16) in regular ecstasy and cannabis users assessing cardiovascular, cognitive and serotonergic effects of 100 mg oral MDMA, vapourised THC (4–6 mg) alone and combined.

Target Enrollment
16 participants
Study Type
interventional
Design
Randomized, double Blind
Registry
NTR / NL1271

Detailed Description

Double-blind, randomised, placebo-controlled crossover in 16 regular ecstasy and cannabis users evaluating acute interactions between 100 mg oral MDMA and vapourised THC (reported 4 mg and 6 mg doses) given alone and in combination.

Primary outcomes include cardiovascular measures (systolic/diastolic blood pressure, heart rate, core temperature) and repeated state measures of psychomotor performance, memory (n-back), sedation (reaction time, saccadic velocity) and subjective effects (Bond and Lader VAS, VAS Bowdle). Secondary measures include serum catecholamines, cortisol, prolactin and drug/metabolite levels; side effects monitored throughout.

Study Arms & Interventions

MDMA 100 mg

experimental

Single oral 100 mg MDMA session (crossover).

Interventions

  • MDMA100 mg
    via Oral• single dose

    100 mg oral MDMA given in single dosing sessions.

THC vaporised

experimental

THC vaporised sessions at low and high doses (crossover).

Interventions

  • Compound4 mg
    via Inhalation• single dose

    THC vaporised (4 mg and 6 mg reported doses across sessions).

MDMA + THC

experimental

Combined MDMA (100 mg) and THC (vaporised) administration.

Interventions

  • MDMA100 mg
    via Oral• single dose

    MDMA 100 mg combined with vaporised THC in crossover sessions.

  • Compound
    via Inhalation• single dose

    THC vaporised (4 mg or 6 mg) combined with MDMA.

Placebo

inactive

Placebo oral and placebo vaporised conditions (crossover control).

Interventions

  • Placebo
    via Oral• single dose

    Oral placebo matched to MDMA.

  • Placebo
    via Inhalation• single dose

    Vapour/placebo matched to THC.

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • 1. Subjects must be at least 18 but not older than 40 years of age.
  • 2. Subjects must have used ecstasy on at least 8 separate occasions during the past two years.
  • 3. Subjects must be regular users of THC; on average 2 units per week.
  • 4. They must have good physical and mental health as determined by medical history and medical, ECG and laboratory examination.
  • 5. Their body weight should be between 80 and 130% of the ideal bodyweight (as defined in the Metropolitan Life Insurance tables), but not less than 60 kg.
  • 6. Written informed consent.
  • 7. Willing and able to apply an appropriate means of contraception for the duration of the treatment period.

Exclusion Criteria

  • 1. History of prescribed medication within the month prior to the start of treatment with trial medication with the exception of oral contraceptives.
  • 2. History of OTC medication within 1 month prior to the start of treatment with trial medication with the exception of occasional use of paracetamol.
  • 3. History of opiate, LSD, amphetamine, cannabis, cocaine, alcohol, solvents or barbiturate abuse.
  • 4. Family history of schizophrenia.
  • 5. Medical or surgical history that in the investigator’s view may significantly affect the outcome of the trial (e.g., cardiovascular disorders, neurological disorders including epilepsy, migraine and dyslexia, psychiatric and personality disorders including depression, anxiety and schizophrenia, gastro-intestinal, renal or hepatic disorders, hormonal disorders such as diabetes mellitus, and coagulation, haematological or cerebrovascular disorders; severe visual impairment).
  • 6. Positive drug/alcohol screen before each experiment.
  • 7. Unable to refrain from smoking during study day.
  • 8. Febrile illness within 3 days before the first dose.
  • 9. Clinically significant abnormal laboratory, ECG and/or EEG abnormalities; subjects showing strong ECG and muscle artefacts that cannot be circumvented by repositioning electrodes.
  • 10. Blood pressure at rest systolic > 170 mm Hg or diastolic > 100 mm Hg.
  • 11. Unable or unwilling to use adequate contraception.
  • 12. Pregnant or lactating.
  • 13. Participation in another drug study within 6 months preceding this study.
  • 14. Orthostatic dysregulation at the screening examination.
  • 15. Training of cognitive tests took place more than 15 days before the start of the experimental period (day −1).
  • 16. Inability to understand the nature and extent of the trial and the procedures required.

Study Details

Locations

Netherlands

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