Safety profile and pharmacokinetics of a synthetic cannabinoid (JHW-018)

Completed

Conditions: Veiligheid
not applicable

Registration Number: NL-OMON46849

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 55

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
* 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

* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>vital signs; ECG, blood pressure, heart rate, saturation, respiration,<br /><br>hematology, biochemistry and urinalysis.<br /><br>Amendement 5: cognitive functions and subjective experience</p><br>

Secondary Outcome Measures