INTERVENTIONALCOMPLETEDNCT02061020

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 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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2016-06-09

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: NA
Enrollment: 37 (ACTUAL)
Start date: 2014-01
Sponsor: Assistance Publique - Hôpitaux de Paris
Design: RANDOMIZED · CROSSOVER · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

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

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

Delta(9)-tetrahydrocannabinol

Medicines

No exact medicine-name link was found.

Research network

Researchers and organizations

Bibiana Cardozo Islam Amine Larabi jean claude ALVAREZ Nicolas Simon Sarah Hartley Assistance Publique – Hôpitaux de Paris Centre de recherche en Epidémiologie et Santé des Populations Economic & Social Sciences, Health Systems & Medical Informatics Hôpital Raymond-Poincaré Inserm Institut de Recherche pour le Développement Université de Versailles Saint-Quentin-en-Yvelines Université Paris-Saclay

Interventions

What was registered

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.

Eligibility

Population and criteria

Sex: MALE
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepted

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

primary measures

Ability to drive a motor vehicle measured using a driving simulator

Time frame: 0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h

The association between THC blood concentrations and driving performances as measured by deviations from the centre of the road and variations of speed at 0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h after smoking.

secondary outcomes

secondary measures

Psychomotor Vigilance Test (PVT) measures

Time frame: 0h, 1h, 2h, 4h, 6h, 8h, 12h et 24h

The association between THC blood concentration and impaired reaction time on PVT measured sequentially over 24 hours

THC pharmacokinetics of occasional and chronic users over 24 hours

Time frame: 24 hours

THC pharmacokinetics parameters (AUC, T1/2, CMAX) of occasional and chronic users over 24 hours will be modelled using a population nonlinear mixed approach.

24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3

Time frame: 24 hours

24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 \* 3

Publications

Locally readable linked articles

linked publication

Can inhaled cannabis users accurately evaluate impaired driving ability? A randomized controlled trial.

Frontiers in Public Health · Free full text

Snapshot provenance

Snapshot: 218938e7-7e72-4a00-8cb0-4c2d4b207cd8
Retrieved: 11/09/2026, 14:17:20
SHA-256: 816d2fb1554148063f461fa3f129f24db06ab4c942259372b9a90bdbeafef1c3