Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users

NACompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

March 31, 2016

Conditions
Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users
Interventions
DRUG

Cannabis (THC) in cigarettes of 30mg, 10mg and placebo

"Smoked THC containing cigarettes. Randomly allocated dosage 30mg, 10mg et placebo.~Both chronic and occasional cannabis consuming volunteers will be allocated to smoking a cigarette containing (1) no THC (placebo), (2) a joint containing 1% THC (10 mg THC, i.e. low-dose) and (3) a joint containing 3% (30 mg THC) mixed with 1 g tobacco.~Each cigarette will be followed by 24 hours testing in laboratory conditions. Each period is separated by 7 days (3 testing periods over 3 weeks). Each volunteer will undergo performance testing (driving simulator and PVT) before administration of the substance (T0).~Blood samples and repeat performance testing will be carried out at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours."

Trial Locations (1)

92380

Raymond Poincare Hospital, Garches

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT02061020 - Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users | Biotech Hunter | Biotech Hunter