Verified April 2016 by Yale University
Sponsor:
Collaborators:
Hartford Hospital
National Institute on Drug Abuse (NIDA)
Montana State University
Maastricht University
The Mind Research Network
Information provided by (Responsible Party):
Godfrey Pearlson, Yale University
ClinicalTrials.gov Identifier:
NCT02757313
First received: April 11, 2016
Last updated: April 28, 2016
Last verified: April 2016
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.
| Marijuana Impairment | Drug: Low dose THC marijuana Drug: High dose THC marijuana Drug: Placebo marijuana |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Neuroscience of Marijuana Impaired Driving |
- Marijuana performance changes on the Tower of London task. [ Time Frame: Baseline and post drug administration at: 0.5 hours; 2.5 hours; 4.5 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 Critical Tracking Task. [ Time Frame: Baseline and post drug administration at: 0.5 hours; 2.5 hours; 4.5 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 Cogstate 1-back/2-back task. [ Time Frame: Baseline and post drug administration at: 0.5 hours; 2.5 hours; 4.5 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: Baseline and post drug administration at: 0.5 hours; 2.5 hours; 4.5 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: Baseline and post drug administration at: 0.5 hours; 2.5 hours; 4.5 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.
- Change in concentration of THC/metabolites in oral fluid tested using Draeger Drug Detection Kits [ Time Frame: Baseline and post drug administration at 9 time points throughout the day ]
Saliva samples will be taken at 10 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 9 time points throughout the day ]
Saliva samples will be taken at 10 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 cannabinol in oral fluid tested using Quantisal Oral Fluid Collection devices. [ Time Frame: Baseline and post drug administration at 9 time points throughout the day ]
Saliva samples will be taken at 10 total time points throughout the day using the Quantisal Oral Fluid Collection devices to assess for changes in concentration of cannabinol.
- Change in concentration of cannabidiol in oral fluid tested using Quantisal Oral Fluid Collection devices. [ Time Frame: Baseline and post drug administration at 9 time points throughout the day ]
Saliva samples will be taken at 10 total time points throughout the day using the Quantisal Oral Fluid Collection devices to assess for changes in concentration of cannabidiol.
- Change in concentration of THC/metabolites in blood samples. [ Time Frame: Baseline and post drug administration at 11 time points throughout the day ]
Blood samples will be taken at 12 total time points throughout the day to assess for changes in concentration of THC and its metabolites.
- Change in concentration of cannabinol in blood samples. [ Time Frame: Baseline and post drug administration at 11 time points throughout the day ]
Blood samples will be taken at 12 total time points throughout the day to assess for changes in concentration of cannabinol.
- Change in concentration of cannabidiol in blood samples. [ Time Frame: Baseline and post drug administration at 11 time points throughout the day ]
Blood samples will be taken at 12 total time points throughout the day to assess for changes in concentration of cannabidiol.
- Change in performance on fMRI simulated driving Road Tracking Task. [ Time Frame: Post drug administration at: 1 hour, 3 hours and 5 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: 1 hour, 3 hours and 5 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 performance on fMRI simulated driving Gap Acceptance Task [ Time Frame: Post drug administration at: 1 hour, 3 hours and 5 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 Set-Shifting paradigm. [ Time Frame: Post drug administration at: 1 hour, 3 hours and 5 hours ]
The set shifting paradigm measures attentional and executive domains.
- Change in performance on fMRI Time Estimation paradigm. [ Time Frame: Post drug administration at: 1 hour, 3 hours and 5 hours ]
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.
| Estimated Enrollment: | 96 |
| Study Start Date: | May 2016 |
| Estimated Primary Completion Date: | May 2020 (Final data collection date for primary outcome measure) |
| Experimental: Regular Users
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. |
Drug: Low dose THC marijuana
Other Name: THC, cannabis Drug: High dose THC marijuana Other Name: THC, cannabis Drug: Placebo marijuana Other Name: THC, cannabis |
| Experimental: Occasional Users
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. |
Drug: Low dose THC marijuana
Other Name: THC, cannabis Drug: High dose THC marijuana Other Name: THC, cannabis Drug: Placebo marijuana Other Name: THC, cannabis |
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.
| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Must have a current driver’s license
- Have used marijuana before
- Right handed
Exclusion Criteria:
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02757313
Yale University
Hartford Hospital
National Institute on Drug Abuse (NIDA)
Montana State University
Maastricht University
The Mind Research Network
| Principal Investigator: | Godfrey Pearlson | Founding Director Olin Research Center; Professor Yale University |
| Responsible Party: | Godfrey Pearlson, Founding Director Olin Neuropsychiatry Research Center; Professor Yale University, Yale University |
| ClinicalTrials.gov Identifier: | NCT02757313 History of Changes |
| Other Study ID Numbers: | HHC-2015-0126 1R01DA038807-01A1 |
| Study First Received: | April 11, 2016 |
| Last Updated: | April 28, 2016 |
| Health Authority: | United States: Food and Drug Administration |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by Yale University:
| marijuana driving THC |
cannabis intoxication MRI |
Additional relevant MeSH terms:
| Marijuana Abuse Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |
ClinicalTrials.gov processed this record on September 13, 2016