Clinical trial 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
Official title: Pilot Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol and the Ability to Drive in Chronic or Occasional Cannabis Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users
Keywords: delta-9-tetrahydrocannabinol, volunteers, cannabis users
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study of the effects of smoked cannabis consumption on performance on a driving simulator and reaction time. The study aims to explore the relationship between concentrations of cannabis in the blood, driving performance and reaction time.

Detailed description: This study will examine:

* The relationship between THC blood levels and driving performance measured on a York Driving simulator
* The relationship between THC blood levels and reaction times as measured on the psychomotor vigilance test (PVT)
* the pharmacokinetics of THC in occasional and chronic cannabis consumers
* Determine the minimum blood concentration level of THC and 11-OH-THC, below which no effect of cannabis is observed
* Determine whether the polymorphism of CYP2C9 (\* 3) is associated with the AUC, Cmax, and higher THC T1/2
* Determine if the polymorphism of CYP2C9 (\* 3) is associated with different pharmacodynamic effects at a given THC level on performance measured by driving simulation

Eligibility criteria: Inclusion criteria:

* Healthy volunteer of male gender from 18 to 25 years
* Normal medical examination
* Driving license owner
* BMI between 18.5 and 25
* moderate tobacco consumption
* moderate consumption of coffee, tea, cola (≤ 225mg caffeine per day)
* Cannabis user for at least 1 year
* Occasional (1-2 joints per week) or chronic (1-2 joints per day) cannabis consumers
* Availability during the study
* Signed consent

Exclusion criteria:

* Participation in another clinical study
* Having taken any psychotropic medication in the past one month
* Having taken any narcotic (alcohol, psychotropic drugs, other narcotics) other than THC in the past 3 days (negative urinary test at inclusion)
* Alcohol blood level positive at inclusion
* Excessive alcohol consumption (AUDIT score \> 7)
* Dependence, present or past, to any psychotropic product (alcohol, psychoactive drugs, other narcotic)
* Depression
* Sleep disorders
* Any psychiatric history, including psychosis
* Deprived of their liberty by judicial or administrative decision
* Lack of medical insurance
* Professional use of motorized vehicles

Primary outcomes:
measure: Ability to drive a motor vehicle measured using a driving simulator
timeFrame: 0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h
Secondary outcomes:
measure: Psychomotor Vigilance Test (PVT) measures
timeFrame: 0h, 1h, 2h, 4h, 6h, 8h, 12h et 24h
measure: THC pharmacokinetics of occasional and chronic users over 24 hours
timeFrame: 24 hours
measure: 24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3
timeFrame: 24 hours
Other outcomes:
Locations:
city: Garches
country: France
facility: Raymond Poincare Hospital
Study officials:
affiliation: Sleep Disorders Unit - Raymond Poincaré Hospital
name: Sarah Hartley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alvarez JC, Hartley S, Etting I, Ribot M, Derridj-Ait-Younes N, Verstuyft C, Larabi IA, Simon N. Population pharmacokinetic model of blood THC and its metabolites in chronic and occasional cannabis users and relationship with on-site oral fluid testing. Br J Clin Pharmacol. 2021 Aug;87(8):3139-3149. doi: 10.1111/bcp.14724. Epub 2021 Jan 12.
citation: Hartley S, Simon N, Larabi A, Vaugier I, Barbot F, Quera-Salva MA, Alvarez JC. Effect of Smoked Cannabis on Vigilance and Accident Risk Using Simulated Driving in Occasional and Chronic Users and the Pharmacokinetic-Pharmacodynamic Relationship. Clin Chem. 2019 May;65(5):684-693. doi: 10.1373/clinchem.2018.299727. Epub 2019 Mar 14.