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van CCT (UK)

van CCT (UK)

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

- candidate number25349
- NTR NumberNTR6141
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-sep-2016
- Secondary IDsMETC 153007 Medisch Ethische Toetsingscommissie Maastricht
- Public TitleSafety profile and pharmacokinetics of a synthetic cannabinoid (JWH-018)
- Scientific TitleSafety profile and pharmacokinetics of a synthetic cannabinoid (JWH-018)
- hypothesisThe primary objective is to determine whether JWH-018 can be safely administered in healthy volunteers in doses up to 3 mg. Therefore participants will be continuously monitored by a medical doctor and vital signs, laboratory clinical safety and side effects will be measured up until 12 hours after administration of the drug.
Secondary measures include pharmacokinetics, cognitive performance (cognitive test), mood and subjective drug experience (questionnaires).
- Healt Condition(s) or Problem(s) studiedCannabis
- 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 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2015
- planned closingdate1-sep-2017
- Target number of participants6
- Interventions0, 2 and 3 mg JWH-018
- Primary outcomevital signs (body temperature, blood pressure, heart rate and respiratory rate), clinical laboratory safety (haematology, clinical chemistry and urinalysis) and side effects
- Secondary outcomePharmacokinetics
- Timepointsmeasurements will take place up until 12 hours after administration
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Maastricht University
- Funding
(Source(s) of Monetary or Material Support)
European Union
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD30-sep-2016 - 22-jan-2017

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