Interactions between... — Clinical Trial Details

Participants

Ages

18 – 40

Sexes

Male & Female

BMI

Psychosis History

Excluded

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.

Company

Product

Legal

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

Detailed Description

Study Arms & Interventions

MDMA 100 mg

Interventions

THC vaporised

Interventions

Locations

MDMA + THC

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details