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

Assistance Publique - Hôpitaux de Paris

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02061020

AOR12144 / P111114

2013-A00245-40 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 37 patients

Sex: Male

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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37 participants in 3 patient groups

Sequence 1

Experimental group

Description:

1. THC containing cigarettes 10mg 2. THC containing cigarettes 30mg 3. Placebo

Treatment:

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

Sequence 2

Experimental group

Description:

1. THC containing cigarettes 30mg 2. Placebo 3. THC containing cigarettes 10mg

Treatment:

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

Sequence 3

Experimental group

Description:

1. Placebo 2. THC containing cigarettes 10mg 3. THC containing cigarettes 30mg

Treatment:

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