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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)

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ClinicalTrials.gov Identifier: NCT02061020
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users Drug: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: Sequence 1
  1. THC containing cigarettes 10mg
  2. THC containing cigarettes 30mg
  3. Placebo
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.


Experimental: Sequence 2
  1. THC containing cigarettes 30mg
  2. Placebo
  3. THC containing cigarettes 10mg
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.


Experimental: Sequence 3
  1. Placebo
  2. THC containing cigarettes 10mg
  3. THC containing cigarettes 30mg
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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061020


Locations
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France
Raymond Poincare Hospital
Garches, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Sarah Hartley, MD Sleep Disorders Unit - Raymond Poincaré Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02061020     History of Changes
Other Study ID Numbers: AOR12144 / P111114
2013-A00245-40 ( Other Identifier: IDRCB )
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: May 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
delta-9-tetrahydrocannabinol, volunteers, cannabis users

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists