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

Study 1: The study is carried out in a limited number of participants (N = 6). These subjects will be given placebo and JWH-018 in increasing doses.
Test subjects will be given one by one (on different days), 2mg JWH-018, after which their vital signs monitored up to 12 hours after administration. At regular intervals, saliva, blood and urine samples taken. In addition, cognitive function and subjective experience also measured regularly. The next person will only start with the study when there are no substantial, drug-related adverse events have occurred in the previous person. An interim analysis will be carried out when 3 and 6 persons have completed this condition.
The next part of the study, involving 3 mg JWH-018, will only start when no substantial effects have been reported with the 2mg dose. Also in this condition subjects are tested one by one, and the following subject can start only when the last day of testing was completed without substantial side effects. Side effects up to 72 hours after administration are reported. An interim analysis will be carried out when 3 people have completed this condition.

Study 2: A new group (amendment 3) of 12 subjects will be given 75µ JWH-018/kg bodyweigh and placebo. Also in this part, participants are tested one by one (on different days), and a next person will only start with the study when there are no substantial, drug-related adverse events have occurred in the previous person. Side effects up to 72 hours after administration are reported. An interim analysis will be carried out when 6 persons have completed this condition.

Study 3: A third groep (amendement 5) of 24 participants will receive 75 µg/kg JWH-018 bodyweight and placebo. When 15 minutes after administration, the subjective intoxication scale indicates that the participant does not experience a drug effect, a booster dose of 50 µg/kg JWH-018 will be administered 30 minutes after the first treatment. This will be repeated if after another 15 minutes later there is still no drug effect experienced. Participants are tested one by one (on different days), and a next person will only start with the study when there are no substantial, drug-related adverse events have occurred in the previous person. Side effects up to 72 hours after administration are reported.

The 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).

measurements will take place up until 12 hours after administration (study 1 and 2) and up until 4h after administration (study 3)

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