Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
13 participants
OBSERVATIONAL
2018-07-01
2023-12-31
Brief Summary
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This study will aim to investigate the brain and behavior in the same individuals, using a similar design to the current Neuroscience of Marijuana Impaired Driving and the prior Alcohol and Driving Grant, that used similar techniques and measures to quantify drunk automobile driving. We hypothesize that alcohol and marijuana use combined will lead to greater impairment in a simulated driving task, as well as other driving-related cognitive impairments. In a randomized, counterbalanced, double-blind study, we will dose participants with alcohol to a legal level of 0.05% blood alcohol content, then we will administer a moderate inhaled dose of THC marijuana or placebo marijuana, using paced inhalation that employees a vaporizer. Participants will comprise 10 regular alcohol and marijuana consumers aged 21 to 40 years of age; all participants must report smoking marijuana and drinking alcohol together. Of the 10, 5 will be occasional marijuana smokers and 5 frequent marijuana smokers. Following this dosing, we will assess impairment through cognitive testing as well as a simulated driving test through fMRI and neuropsychological tests. Samples of breath, blood and oral fluid will also be collected at multiple time points throughout the study visits to be measured for alcohol and THC concentration and its metabolites. This allows clarification between the relationship of impairment, as well as subjective and objective intoxication, and levels of THC and its metabolites in the users system.
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Detailed Description
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Data are being gathered currently in regards to the risk of marijuana-impaired driving from our NIDA-funded Neuroscience of Marijuana Impaired Driving study. Previously we had a grant award from NIAAA that investigated alcohol-impaired driving using a similar design. The current proposed study combines elements of both the NIDA and NIAAA studies, to assess the cognitive and brain impairment due to the simultaneous combination of beverage alcohol and smoked marijuana.
Our own prior NIAAA-funded grant, the Brain and Alcohol Research with College Students (BARCS) study, along with epidemiological investigations reveal that most marijuana smokers also consume alcohol when intoxicated. These drugs interact pharmacodynamically and change each other's levels in the user's blood and saliva reference Marilyn study. They both have separate, deleterious effects on driving. These effects are not additive but rather multiplicative. A person using both substances will show more deleterious effects on driving performance than the same individual using just one of these substances. This study will aim to investigate the brain and behavior in the same individuals, using a similar design to the current Neuroscience of Marijuana Impaired Driving and the prior Alcohol and Driving Grant, that used similar techniques and measures to quantify drunk automobile driving. We hypothesize that alcohol and marijuana use combined will lead to greater impairment in a simulated driving task, as well as other driving-related cognitive impairments. In a randomized, counterbalanced, double-blind study, we will dose participants with alcohol to a legal level of 0.05% blood alcohol content, then we will administer a moderate inhaled dose of THC marijuana or placebo marijuana, using paced inhalation that employees a vaporizer. Participants will comprise 10 regular alcohol and marijuana consumers aged 21 to 40 years of age; all participants must report smoking marijuana and drinking alcohol together. Of the 10, 5 will be occasional marijuana smokers and 5 frequent marijuana smokers. Following this dosing, we will assess impairment through cognitive testing as well as a simulated driving test through fMRI and neuropsychological tests. Samples of breath, blood and oral fluid will also be collected at multiple time points throughout the study visits to be measured for alcohol and THC concentration and its metabolites. This allows clarification between the relationship of impairment, as well as subjective and objective intoxication, and levels of THC and its metabolites in the users system.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Marijuana Users
One day with a dose of placebo cannabis paired with alcohol
Vaporized placebo marijuana with little to no THC paired with drinking alcohol to BrAC of 0.05%
One day with a dose of active THC cannabis paired with alcohol
Vaporized marijuana with active THC paired with drinking alcohol to BrAC of 0.05%
Interventions
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One day with a dose of placebo cannabis paired with alcohol
Vaporized placebo marijuana with little to no THC paired with drinking alcohol to BrAC of 0.05%
One day with a dose of active THC cannabis paired with alcohol
Vaporized marijuana with active THC paired with drinking alcohol to BrAC of 0.05%
Eligibility Criteria
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Inclusion Criteria
* Must have used marijuana and alcohol in combination before
* Right handed
Exclusion Criteria
* Unable or unsafe to have an MRI
* Any serious medical or neurological disorder
* Any psychiatric disorder
* No major head traumas
21 Years
40 Years
ALL
Yes
Sponsors
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Hartford Hospital
OTHER
Responsible Party
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Locations
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Olin Neuropsychiatry Research Center, Institute of Living, Hartford Hospital
Hartford, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HHC-2016-0183
Identifier Type: -
Identifier Source: org_study_id
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