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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)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cannabis (THC) in cigarettes of 30mg, 10mg and placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users focused on measuring delta-9-tetrahydrocannabinol, volunteers, cannabis users

Eligibility Criteria

18 Years - 25 Years (Adult)MaleAccepts 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

Sites / Locations

  • Raymond Poincare Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Arm Description

THC containing cigarettes 10mg THC containing cigarettes 30mg Placebo

THC containing cigarettes 30mg Placebo THC containing cigarettes 10mg

Placebo THC containing cigarettes 10mg THC containing cigarettes 30mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Psychomotor Vigilance Test (PVT) measures
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
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 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3

Full Information

First Posted
December 18, 2013
Last Updated
June 8, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02061020
Brief Title
Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users
Keywords
delta-9-tetrahydrocannabinol, volunteers, cannabis users

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
THC containing cigarettes 10mg THC containing cigarettes 30mg Placebo
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
THC containing cigarettes 30mg Placebo THC containing cigarettes 10mg
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
Placebo THC containing cigarettes 10mg THC containing cigarettes 30mg
Intervention Type
Drug
Intervention Name(s)
Cannabis (THC) in cigarettes of 30mg, 10mg and placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ability to drive a motor vehicle measured using a driving simulator
Description
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.
Time Frame
0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h
Secondary Outcome Measure Information:
Title
Psychomotor Vigilance Test (PVT) measures
Description
The association between THC blood concentration and impaired reaction time on PVT measured sequentially over 24 hours
Time Frame
0h, 1h, 2h, 4h, 6h, 8h, 12h et 24h
Title
THC pharmacokinetics of occasional and chronic users over 24 hours
Description
THC pharmacokinetics parameters (AUC, T1/2, CMAX) of occasional and chronic users over 24 hours will be modelled using a population nonlinear mixed approach.
Time Frame
24 hours
Title
24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3
Description
24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3
Time Frame
24 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Hartley, MD
Organizational Affiliation
Sleep Disorders Unit - Raymond Poincaré Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raymond Poincare Hospital
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33386756
Citation
Alvarez JC, Hartley S, Etting I, Ribot M, Derridj-Ait-Younes N, Verstuyft C, Larabi IA, Simon N. Population pharmacokinetic model of blood THC and its metabolites in chronic and occasional cannabis users and relationship with on-site oral fluid testing. Br J Clin Pharmacol. 2021 Aug;87(8):3139-3149. doi: 10.1111/bcp.14724. Epub 2021 Jan 12.
Results Reference
derived
PubMed Identifier
30872375
Citation
Hartley S, Simon N, Larabi A, Vaugier I, Barbot F, Quera-Salva MA, Alvarez JC. Effect of Smoked Cannabis on Vigilance and Accident Risk Using Simulated Driving in Occasional and Chronic Users and the Pharmacokinetic-Pharmacodynamic Relationship. Clin Chem. 2019 May;65(5):684-693. doi: 10.1373/clinchem.2018.299727. Epub 2019 Mar 14.
Results Reference
derived

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

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