Marijuana ImpairmentPhase 1MJDrivingNCT02757313
Neuroscience of Marijuana Impaired Driving
A Phase 1 study testing Low dose THC marijuana and High dose THC marijuana in people with Marijuana Impairment, run by Yale University at 1 site in United States.
Trial summary
Marijuana is one of the most widely used substances. However, marijuana intoxication is not fully understood in relation to driving. This study will help the investigators learn more about the potential impairments related to marijuana intoxicated driving. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Impairment
- What is being tested?
- Low dose THC marijuana and High dose THC marijuana
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to May 2021
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have a current driver's license
- Have used marijuana before
- Right handed
Who cannot join
- Females who are pregnant or breast feeding
- Unable or unsafe to have an MRI
- Any serious medical, or neurological disorder
- Any psychiatric disorder
- No major head traumas
Trial locations and contacts
1 site in 1 country.
United States1 site
Olin Neuropsychiatry Research Center
Hartford, Connecticut, 06106
About this study
Marijuana is one of the most widely used substances. However, marijuana intoxication is not fully understood in relation to driving. This study will help the investigators learn more about the potential impairments related to marijuana intoxicated driving. A combination of MRI and neuropsychological tests (which are computer and paper/pencil tasks) will be used to measure intoxication and impairment. This study will also assess levels of marijuana in blood and saliva samples. This study takes place in Hartford, Connecticut.
Read the detailed description
Cannabis is a commonly abused drug whose use cuts across social class, is linked to cognitive impairment, and may be a major contributor to intoxication-related accidents - either alone or with alcohol. However, cannabis intoxication is little studied in relation to driving compared to alcohol. Not only does the current NHTSA Strategic Plan for Behavioral Research prioritize understanding how drugs other than alcohol contribute to traffic crashes, it has recently become more pressing to understand the effects of cannabis because of increasing rates of legalized medical and/or recreational use, that will likely result in more cannabis intoxicated drivers. Social and legal policy will be unable to effectively address the many concerns about driving safety raised by more frequent and widespread use of cannabis without new research to better determine the parameters within which cannabis use does, or does not, increase automobile accident risk. The purpose of this study is to better describe specific, driving-related cognitive impairments caused by acute cannabis intoxication, their persistence over time, underlying functional brain anatomy, and relationship to performance on a state-of the art validated simulated driving task in which the investigators have prior experience. In a randomized, counterbalanced, double-blinded fashion, the investigators will administer two cannabis doses and placebo of smoked cannabis (paced inhalation using a vaporizer) to 48 regular cannabis users and 48 occasional cannabis users on 3 separate occasions. Following cannabis dosing cognitive and driving impairment will be assessed longitudinally for several hours using a combination of fMRI and neuropsychological tests, to clarify relationships between subjective and objective measures of intoxication and of impairment, that include expert assessment of THC and its metabolite levels in blood and saliva. This study takes place in Hartford, Connecticut.
- Conditions
- Marijuana Impairment
- Being tested
- Low dose THC marijuana, High dose THC marijuana, Placebo marijuana
- Keywords
- marijuana, driving, THC, cannabis, intoxication, MRI
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose THC marijuanaDrug
Also called THC, cannabis
High dose THC marijuanaDrug
Also called THC, cannabis
Placebo marijuanaDrug
Also called THC, cannabis
| Study group | Role | What they receive |
|---|---|---|
| Regular Users | Experimental | People who use marijuana regularly will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the study visits. Receives: Drug: Low dose THC marijuana; Drug: High dose THC marijuana; Drug: Placebo marijuana |
| Occasional Users | Experimental | People who use marijuana occasionally will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the study visits. Receives: Drug: Low dose THC marijuana; Drug: High dose THC marijuana; Drug: Placebo marijuana |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance on fMRI simulated driving Gap Acceptance Task
The Gap Acceptance Task measures strategic control of the vehicle. Strategic control of the vehicle is measured by size of headway gaps that the participant chooses in pulling out into a stream of traffic.
Measured: Post drug administration at: 30 min, 3 hours and 5.25 hours
Change in performance on fMRI simulated driving Road Tracking Task.
The Road Tracking Task measures operational control of the vehicle. Operational control is measured by standard deviation of lane position from the center point of the lane.
Measured: Post drug administration at: 30 min, 3 hours and 5.25 hours
Change in performance on fMRI simulated driving Car Following Task.
The Car Following Task measures tactical control of the vehicle. Tactical control of the vehicle is measured by following distance from a lead vehicle.
Measured: Post drug administration at: 30 min, 3 hours and 5.25 hours
Change in concentration of THC/metabolites in oral fluid tested using Draeger Drug Detection Kits
Saliva samples will be taken at 8 total time points throughout the day using the Draeger Drug Detection kits to assess for changes in concentration of THC and its metabolites.
Measured: Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min,
Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
Saliva samples will be taken at 8 total time points throughout the day using the Quantisal Oral Fluid Collection devices to assess for changes in concentration of THC and its metabolites.
Measured: Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min,
Change in concentration of THC/metabolites in blood samples.
Blood samples will be taken at 8 total time points throughout the day to assess for changes in concentration of THC and its metabolites.
Measured: Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min,
Marijuana performance changes on the Critical Tracking Task.
The Critical Tracking Task assesses visuomotor tracking, it will be administered prior to dosing and at various time points after dosing.
Measured: Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
Marijuana performance changes on the Tower of London task.
The Tower of London is a task that assesses executive functioning, it will be administered prior to dosing and at various time points after dosing.
Measured: Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
Marijuana performance changes on the Cogstate 1-back/2-back task.
The Cogstate 1-back/2-back task assesses working memory, it will be administered prior to dosing and at various time points after dosing.
Measured: Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
Marijuana performance changes on the Cogstate Detection Task.
The Cogstate Detection Task assesses processing speed, it will be administered prior to dosing and at various time points after dosing.
Measured: Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
Marijuana performance changes on the Cogstate Set Shifting Task.
The Cogstate Set Shifting Task assesses executive functioning, it will be administered prior to dosing and at various time points after dosing.
Measured: Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
Secondary outcomes (2)
Change in performance on fMRI Set-Shifting paradigm.
The set shifting paradigm measures attentional and executive domains.
Measured: Post drug administration at: 1.25 hours, 3.5 hours and 6 hours
Change in performance on fMRI Time Estimation paradigm.
The time estimation paradigm measures misjudgment of time intervals based on participant responses indicating whether one time interval was the same, longer or shorter than the previous time interval.
Measured: Post drug administration at: 1.25 hours, 3.5 hours and 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana ImpairmentStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Hartford Hospital, National Institute on Drug Abuse (NIDA), Montana State University, Maastricht University, The Mind Research Network
- Responsible party
- Principal investigator, Godfrey Pearlson, Yale University
- Investigators
- Godfrey Pearlson, Principal investigator, Founding Director Olin Research Center; Professor Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757313
- Sponsor's protocol ID
- 1507016175
- Other IDs
- 1R01DA038807-01A1
- Acronym
- MJDriving
- Status last verified
- Jul 2024
- First submitted
- 11 Apr 2016
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroscience of Marijuana Impaired Driving
- ClinicalTrials.gov ID
- NCT02757313
- Acronym / sponsor ID
- MJDriving / 1507016175
- Conditions
- Marijuana Impairment
- Keywords
- marijuana, driving, THC, cannabis, intoxication, MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Hartford Hospital, National Institute on Drug Abuse (NIDA), Montana State University, Maastricht University, The Mind Research Network
- Study start
- Oct 2016
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 2 May 2016 (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.
Marijuana is one of the most widely used substances. However, marijuana intoxication is not fully understood in relation to driving. This study will help the investigators learn more about the potential impairments related to marijuana intoxicated driving. A combination of MRI and neuropsychological tests (which are computer and paper/pencil tasks) will be used to measure intoxication and impairment. This study will also assess levels of marijuana in blood and saliva samples. This study takes place in Hartford, Connecticut.
Detailed description
Cannabis is a commonly abused drug whose use cuts across social class, is linked to cognitive impairment, and may be a major contributor to intoxication-related accidents - either alone or with alcohol. However, cannabis intoxication is little studied in relation to driving compared to alcohol. Not only does the current NHTSA Strategic Plan for Behavioral Research prioritize understanding how drugs other than alcohol contribute to traffic crashes, it has recently become more pressing to understand the effects of cannabis because of increasing rates of legalized medical and/or recreational use, that will likely result in more cannabis intoxicated drivers. Social and legal policy will be unable to effectively address the many concerns about driving safety raised by more frequent and widespread use of cannabis without new research to better determine the parameters within which cannabis use does, or does not, increase automobile accident risk. The purpose of this study is to better describe specific, driving-related cognitive impairments caused by acute cannabis intoxication, their persistence over time, underlying functional brain anatomy, and relationship to performance on a state-of the art validated simulated driving task in which the investigators have prior experience. In a randomized, counterbalanced, double-blinded fashion, the investigators will administer two cannabis doses and placebo of smoked cannabis (paced inhalation using a vaporizer) to 48 regular cannabis users and 48 occasional cannabis users on 3 separate occasions. Following cannabis dosing cognitive and driving impairment will be assessed longitudinally for several hours using a combination of fMRI and neuropsychological tests, to clarify relationships between subjective and objective measures of intoxication and of impairment, that include expert assessment of THC and its metabolite levels in blood and saliva. This study takes place in Hartford, Connecticut.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Users | Experimental | Drug: Low dose THC marijuana, Drug: High dose THC marijuana, Drug: Placebo marijuanaPeople who use marijuana regularly will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the study visits. |
| Occasional Users | Experimental | Drug: Low dose THC marijuana, Drug: High dose THC marijuana, Drug: Placebo marijuanaPeople who use marijuana occasionally will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the study visits. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must have a current driver's license
- Have used marijuana before
- Right handed
Key exclusion criteria (5 listed)
- Females who are pregnant or breast feeding
- Unable or unsafe to have an MRI
- Any serious medical, or neurological disorder
- Any psychiatric disorder
- No major head traumas
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 |
|---|---|---|
| Low dose THC marijuanaAlso: THC, cannabis | Drug | Occasional Users, Regular Users |
| High dose THC marijuanaAlso: THC, cannabis | Drug | Occasional Users, Regular Users |
| Placebo marijuanaAlso: THC, cannabis | Drug | Occasional Users, Regular Users |
Primary outcome
Change in performance on fMRI simulated driving Gap Acceptance Task
Time frame: Post drug administration at: 30 min, 3 hours and 5.25 hours
The Gap Acceptance Task measures strategic control of the vehicle. Strategic control of the vehicle is measured by size of headway gaps that the participant chooses in pulling out into a stream of traffic.
Change in performance on fMRI simulated driving Road Tracking Task.
Time frame: Post drug administration at: 30 min, 3 hours and 5.25 hours
The Road Tracking Task measures operational control of the vehicle. Operational control is measured by standard deviation of lane position from the center point of the lane.
Change in performance on fMRI simulated driving Car Following Task.
Time frame: Post drug administration at: 30 min, 3 hours and 5.25 hours
The Car Following Task measures tactical control of the vehicle. Tactical control of the vehicle is measured by following distance from a lead vehicle.
Change in concentration of THC/metabolites in oral fluid tested using Draeger Drug Detection Kits
Time frame: Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min,
Saliva samples will be taken at 8 total time points throughout the day using the Draeger Drug Detection kits to assess for changes in concentration of THC and its metabolites.
Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
Time frame: Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min,
Saliva samples will be taken at 8 total time points throughout the day using the Quantisal Oral Fluid Collection devices to assess for changes in concentration of THC and its metabolites.
Change in concentration of THC/metabolites in blood samples.
Time frame: Baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min,
Blood samples will be taken at 8 total time points throughout the day to assess for changes in concentration of THC and its metabolites.
Marijuana performance changes on the Critical Tracking Task.
Time frame: Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
The Critical Tracking Task assesses visuomotor tracking, it will be administered prior to dosing and at various time points after dosing.
Marijuana performance changes on the Tower of London task.
Time frame: Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
The Tower of London is a task that assesses executive functioning, it will be administered prior to dosing and at various time points after dosing.
Marijuana performance changes on the Cogstate 1-back/2-back task.
Time frame: Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
The Cogstate 1-back/2-back task assesses working memory, it will be administered prior to dosing and at various time points after dosing.
Marijuana performance changes on the Cogstate Detection Task.
Time frame: Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
The Cogstate Detection Task assesses processing speed, it will be administered prior to dosing and at various time points after dosing.
Marijuana performance changes on the Cogstate Set Shifting Task.
Time frame: Post drug administration at two of the following time points (which varies dependent on the visit day): 2 hours; 4.25 hours; 6.5 hours
The Cogstate Set Shifting Task assesses executive functioning, it will be administered prior to dosing and at various time points after dosing.
2 secondary outcomes
Change in performance on fMRI Set-Shifting paradigm.
Time frame: Post drug administration at: 1.25 hours, 3.5 hours and 6 hours
Change in performance on fMRI Time Estimation paradigm.
Time frame: Post drug administration at: 1.25 hours, 3.5 hours and 6 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 23 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Marijuana Impairment
Not yet recruitingPhase 1
Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance
Cannabis Use, Impaired Driving
Recruiting
Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use
Psychotic Disorders, Cannabis Use Disorder
RecruitingPhase 1
Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
Cannabis Intoxication, Alcohol Intoxication
RecruitingPhase 2
CBD for Individuals at Risk for Alzheimer's Disease
Mild Cognitive Impairment
Recruiting
Brief Interventions to Reduce Comorbid Alcohol and Cannabis Misuse and Sleep Impairment in Young Adults (Rest-Up RCT)
Insomnia, Alcohol Use
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.
Godfrey Pearlson principal investigator
Founding Director Olin Research Center; Professor Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose THC marijuana and High dose THC marijuana in people with Marijuana Impairment, run by Yale University at 1 site in United States.
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 3 inclusion and 5 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 23 Jul 2024. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in performance on fMRI simulated driving Gap Acceptance Task (time frame: Post drug administration at: 30 min, 3 hours and 5.25 hours). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2024.