JWH-018, synthetic cannabinoid, safety, pharmacokinetics
Conditions
Interventions
Study 1: 0, 2 and 3 mg JWH-018. Study 2: 75µg/kg JWH-018 and placebo. Study 3: 75µg/kg JWH-018 (+booster dose if needed) and placebo
Sponsors
Maastricht University
Eligibility
Inclusion criteria
Inclusion criteria: • Used cannabis between 2 times a month and 2 times a week during the previous year • Age between 18 and 40 years • Free from psychotropic medication • the subject is, in the opinion of the investigator, generally healthy based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests • a resting pulse and heart rate (as read on the ECG) 51 bpm and 100 bpm. For subjects in good physical condition, the lower limit is 45 bpm. • a resting systolic blood pressure 91 mmHg and 140 mmHg and a resting diastolic blood pressure 51 mmHg and 90 mmHg. • clinical laboratory test values within the reference ranges. Borderline values may be accepted if they are, in the opinion of the investigator, clinically insignificant. • normal binocular visual acuity, corrected or uncorrected • Absence of any major medical, endocrine and neurological condition, as determined by the medical history, medical examination, electrocardiogram and laboratory analyses (haematology, clinical chemistry, urinalysis, serology). • Normal weight, body mass index (weight/height2) between 19,5 and 28 kg/m2 • Written Informed Consent
Exclusion criteria
Exclusion criteria: • History of drug abuse (other than the use of cannabis) or addiction (determined by the medical questionnaire, drug questionnaire and medical examination) • Experience with synthetic cannabis • Pregnancy or lactation • Hypertension (diastolic > 90; systolic > 140) • Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination) • Liver dysfunction • (Serious) side effects to previous cannabis use • History of cardiac dysfunctions (arrhythmia, ischemic heart disease,…) • Simultaneous participation in another clinical trial • For women: no use of a reliable contraceptive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs (body temperature, blood pressure, heart rate and respiratory rate), clinical laboratory safety (haematology, clinical chemistry and urinalysis) and side effects | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and pharmacodynamics | — |
Contacts
Public ContactEef Theunissen
Maastricht University
Outcome results
None listed