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

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

— VIGICANN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061020
• Other study ID #: AOR12144 / P111114
• Secondary ID: 2013-A00245-40
• Status: Completed
• Phase: N/A
• First received: December 18, 2013
• Last updated: June 8, 2016
• Start date: January 2014
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	Raymond Poincare Hospital	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to drive a motor vehicle measured using a driving simulator	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.	0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h	Yes
Secondary	Psychomotor Vigilance Test (PVT) measures	The association between THC blood concentration and impaired reaction time on PVT measured sequentially over 24 hours	0h, 1h, 2h, 4h, 6h, 8h, 12h et 24h	Yes
Secondary	THC pharmacokinetics of occasional and chronic users over 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 hours	No
Secondary	24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3	24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3	24 hours	No