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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sequence 1

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Sequence 2

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Sequence 3

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes