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

Not Applicable

Completed

• 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

• Registration Number: NCT02061020
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study First Submitted: 2013-12-18
• Study Start: 2014-01
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-12
• Primary Completion: 2015-07
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	Cannabis (THC) in cigarettes of 30mg, 10mg and placebo	1. THC containing cigarettes 10mg 2. THC containing cigarettes 30mg 3. Placebo
Sequence 2	Cannabis (THC) in cigarettes of 30mg, 10mg and placebo	1. THC containing cigarettes 30mg 2. Placebo 3. THC containing cigarettes 10mg
Sequence 3	Cannabis (THC) in cigarettes of 30mg, 10mg and placebo	1. Placebo 2. THC containing cigarettes 10mg 3. THC containing cigarettes 30mg

Primary Outcome Measures

Name	Time	Method
Ability to drive a motor vehicle measured using a driving simulator	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 Outcome Measures

Name	Time	Method
Psychomotor Vigilance Test (PVT) measures	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	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	24 hours	24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 \* 3

Trial Locations

Locations (1)

Raymond Poincare Hospital; 🇫🇷 Garches, France