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Completed

NCT Number: NCT03191084

Examine the Feasibility of a Standardized Field Test for Marijuana Impairment: Laboratory Evaluations

Marijuana is one of the most widely used substances. This study will characterize the persistence of cannabis' (CNB's) acute effects on cognitive test performance and simulated driving over a several hour time period. The data obtained from simulated driving, cognitive tests, and biological assays of THC will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk.

Eligible participants will undergo a full day screening visit, if still eligible they will come to Hartford Hospital in Hartford, Connecticut to take part in the full study. Participation requires overnight stays between each of the five study visits. On each of the study days participants are dosed with either a low dose of THC marijuana, a high dose of THC marijuana or placebo marijuana, (the low and high doses are repeated once each, order in which the study drug is given is double blind and chosen at random.)

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Key information

Conditions

Marijuana Impairment Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Olin Neuropsychiatry Research Center

Hartford, Connecticut, 06106, United States

About this study

This responds to NHTSA's request with a proposal to increase our understanding of smoked cannabis' (CNB's) acute effects on cognition and simulated driving performance, the persistence of these deficits over the hours after use, and the influence of prior experience with CNB on these effects. The project also will link an extensive literature on CNB's effects on laboratory cognitive tests to simulated driving performance for the first time, providing a crucial validation of CNB's neurofunctional effects identifying maximally relevant candidate measures for field sobriety tests. To this goal, the proposed study was based upon a careful and thorough review of the scientific literature describing CNB effects on cognitive test performance and driving, as well as current state-of-knowledge on the sensitivity of biological assays for identifying recent CNB use. The study will carefully characterize the persistence of CNB's acute effects on cognitive test performance and driving over a several-hour time span. This will allow us to identify the point at which any effects of CNB intoxication on cognitive tests and driving performance cannot be distinguished from normal, i.e., the first step towards establishing standards for legal and social policy. The data obtained from simulated driving, cognitive tests, and biological assays of THC will be used in analyses aimed at identifying what tests or combination of tests predict both recent use and driving impairment risk.

Participants

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have a current driver's license
  • Have used marijuana before
  • Right handed

Exclusion criteria

  • Females who are pregnant or breast feeding
  • Any serious medical, or neurological disorder
  • Any psychiatric disorder
  • No major head traumas

Treatment and study plan

Low Dose THC Marijuana

Drug

Dosing via vaporized marijuana using a lower concentration of THC, participants receive this dose on two of the five study visits.

Other names: THC, Cannabis

High Dose THC Marijuana

Drug

Dosing via vaporized marijuana using a higher concentration of THC, participants receive this dose on two of the five study visits.

Other names: THC, Cannabis

Placebo Marijuana

Drug

Dosing via vaporized marijuana with no THC, participants receive this dose on one of the five study visits.

Other names: THC, Cannabis

Primary outcomes

  1. Marijuana induced performance changes on Cogstate 1-back/2-back task.

    Time frame: Baseline and post drug administration at: 10 min; 1.5 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.

  2. Marijuana induced performance changes on Cogstate Card Learning.

    Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours

    The Cogstate Card Learning task assesses visual memory, it will be administered prior to dosing and at various time points after dosing.

  3. Marijuana induced performance changes on Cogstate Groton Maze Learning task.

    Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours

    The Cogstate Groton Maze Learning task assesses spatial learning and memory, it will be administered prior to dosing and at various time points after dosing.

  4. Marijuana induced performance changes on Cogstate Social/Emotional Cognition task.

    Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours

    The Cogstate Social/Emotional Cognition task assesses emotional processing, it will be administered prior to dosing and at various time points after dosing.

  5. Marijuana induced performance changes on Alertmeter.

    Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours

    The Alertmeter task assess visual judgment and alertness, it will be administered prior to dosing and at various time points after dosing.

  6. Marijuana induced performance changes on the Time Estimation Task.

    Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours

    The Time Estimation Task assesses timing, it will be administered prior to dosing and at various time points after dosing.

  7. Marijuana induced performance changes on the Stop Signal Reaction Time task.

    Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours

    The Stop Signal Reaction Time Task assesses inhibitory processing, it will be administered prior to dosing and at various time points after dosing.

  8. Marijuana induced performance changes on the Critical Tracking Task.

    Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours

    The Critical Tracking Task assesses hand eye coordination and visuomotor tracking, it will be administered prior to dosing and at various time points after dosing.

  9. Marijuana induced performance changes on the ANAM Pursuit Tracking Task.

    Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours

    The ANAM Pursuit Tracking Task assesses hand eye coordination, it will be administered prior to dosing and at various time points after dosing.

  10. Marijuana induced performance changes on the Finger to Nose Task.

    Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours

    The Finger to Nose Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.

  11. Marijuana induced performance changes on the One Leg Stand Task.

    Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours

    The One Leg Stand Task assesses general motor coordination, it will be administered prior to dosing and at various time points after dosing.

  12. Marijuana induced performance changes on the Line Walking/Months Backwards Task.

    Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours

    The Line Walking/Months Backwards Task assesses general motor coordination plus distraction, it will be administered prior to dosing and at various time points after dosing.

  13. Marijuana induced performance changes on the Time Reproduction Task.

    Time frame: Baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours; 4.5 hours; 6.5 hours

    The Time Reproduction Task assesses general motor coordination plus timing, it will be administered prior to dosing and at various time points after dosing.

Secondary outcomes

  1. 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 with be collected at 8 times throughout each day to assess for changes of THC and its metabolite levels.

  2. 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.

    Oral fluid samples with be collected at 8 times throughout each day to assess for changes of THC and its metabolite levels.

  3. 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.

    Oral fluid samples with be collected at 8 times throughout each day to assess for changes of THC and its metabolite levels.

  4. Change in performance on 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.

  5. Change in performance on 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.

  6. Change in performance on 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 oncoming traffic to overtake a stopped car.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Hartford Hospital
  • Maastricht University
  • Montana State University
  • National Highway Traffic Safety Administration (NHTSA)
  • National Institute on Drug Abuse (NIDA)
  • The Mind Research Network

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2017
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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