Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis UsersVIGICANNNCT02061020
Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users
A study of Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 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.
Read the 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
- Being tested
- Cannabis (THC) in cigarettes of 30mg, 10mg and placebo
- Keywords
- delta-9-tetrahydrocannabinol, volunteers, cannabis users
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis (THC) in cigarettes of 30mg, 10mg and placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | 1. THC containing cigarettes 10mg
2. THC containing cigarettes 30mg
3. Placebo Receives: Drug: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo |
| Sequence 2 | Experimental | 1. THC containing cigarettes 30mg
2. Placebo
3. THC containing cigarettes 10mg Receives: Drug: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo |
| Sequence 3 | Experimental | 1. Placebo
2. THC containing cigarettes 10mg
3. THC containing cigarettes 30mg Receives: Drug: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h
Secondary outcomes (3)
Psychomotor Vigilance Test (PVT) measures
The association between THC blood concentration and impaired reaction time on PVT measured sequentially over 24 hours
Measured: 0h, 1h, 2h, 4h, 6h, 8h, 12h et 24h
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.
Measured: 24 hours
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis UsersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Hartley, MD, Principal investigator, Sleep Disorders Unit - Raymond Poincaré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061020
- Sponsor's protocol ID
- AOR12144 / P111114
- Other IDs
- 2013-A00245-40
- Acronym
- VIGICANN
- Status last verified
- May 2016
- First submitted
- 18 Dec 2013
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hartley S, Simon N, Cardozo B, Larabi IA, Alvarez JC. Can inhaled cannabis users accurately evaluate impaired driving ability? A randomized controlled trial. Front Public Health. 2023 Nov 22;11:1234765. doi: 10.3389/fpubh.2023.1234765. eCollection 2023.
PubMed 38074719Alvarez 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.
PubMed 33386756Hartley 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.
PubMed 30872375
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02061020
- Acronym / sponsor ID
- VIGICANN / AOR12144 / P111114
- Keywords
- delta-9-tetrahydrocannabinol, volunteers, cannabis users
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo1. THC containing cigarettes 10mg 2. THC containing cigarettes 30mg 3. Placebo |
| Sequence 2 | Experimental | Drug: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo1. THC containing cigarettes 30mg 2. Placebo 3. THC containing cigarettes 10mg |
| Sequence 3 | Experimental | Drug: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo1. Placebo 2. THC containing cigarettes 10mg 3. THC containing cigarettes 30mg |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis (THC) in cigarettes of 30mg, 10mg and placeboSmoked 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. | Drug | Sequence 1, Sequence 2, Sequence 3 |
Primary outcome
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.
3 secondary outcomes
Psychomotor Vigilance Test (PVT) measures
Time frame: 0h, 1h, 2h, 4h, 6h, 8h, 12h et 24h
THC pharmacokinetics of occasional and chronic users over 24 hours
Time frame: 24 hours
24 hoursTHC pharmacokinetics (AUC, T1 / 2, CMAX) and its relationships with genotype CYP2C9 * 3
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Derived from this study: PubMed 38074719Hartley S, Simon N, Cardozo B, Larabi IA, Alvarez JC. Can inhaled cannabis users accurately evaluate impaired driving ability? A randomized controlled trial. Front Public Health. 2023 Nov 22;11:1234765. doi: 10.3389/fpubh.2023.1234765. eCollection 2023.
- Derived from this study: PubMed 33386756Alvarez 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.
- Derived from this study: PubMed 30872375Hartley 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Hartley, MD principal investigator
Sleep Disorders Unit - Raymond Poincaré Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to drive a motor vehicle measured using a driving simulator (time frame: 0h, 1h, 2h, 4h, 6h, 8h, 12h and 24 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02061020, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.