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

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ClinicalTrials.gov Identifier: NCT03191084
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : January 25, 2019
Sponsor:
Collaborators:
National Highway Traffic Safety Administration
Hartford Hospital
Montana State University
Maastricht University
The Mind Research Network
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Godfrey Pearlson, Yale University

Brief Summary:

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.)


Condition or disease Intervention/treatment Phase
Marijuana Impairment Drug: Low Dose THC Marijuana Drug: High Dose THC Marijuana Drug: Placebo Marijuana Early Phase 1

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Examine the Feasibility of a Standardized Field Test for Marijuana Impairment: Laboratory Evaluations
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
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 five study visits.
Drug: Low Dose THC Marijuana
Dosing via vaporized marijuana using a lower concentration of THC, participants receive this dose on two of the five study visits.
Other Name: THC, Cannabis

Drug: High Dose THC Marijuana
Dosing via vaporized marijuana using a higher concentration of THC, participants receive this dose on two of the five study visits.
Other Name: THC, Cannabis

Drug: Placebo Marijuana
Dosing via vaporized marijuana with no THC, participants receive this dose on one of the five study visits.
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 five study visits.
Drug: Low Dose THC Marijuana
Dosing via vaporized marijuana using a lower concentration of THC, participants receive this dose on two of the five study visits.
Other Name: THC, Cannabis

Drug: High Dose THC Marijuana
Dosing via vaporized marijuana using a higher concentration of THC, participants receive this dose on two of the five study visits.
Other Name: THC, Cannabis

Drug: Placebo Marijuana
Dosing via vaporized marijuana with no THC, participants receive this dose on one of the five study visits.
Other Name: THC, Cannabis




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191084


Contacts
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Contact: Catherine Boyle, B.S. 860-545-7548 catherine.boyle@hhchealth.org
Contact: Diana King, B.S. 860-545-7563 Diana.King@hhchealth.org

Locations
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United States, Connecticut
Olin Neuropsychiatry Research Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Diana King, B.S.    850-545-7563    Diana.King@hhchealth.org   
Contact: Catherine Boyle, B.S.    860-545-7548    catherine.boyle@hhchealth.org   
Principal Investigator: Godfrey Pearlson, MD         
Sponsors and Collaborators
Yale University
National Highway Traffic Safety Administration
Hartford Hospital
Montana State University
Maastricht University
The Mind Research Network
National Institute on Drug Abuse (NIDA)

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Responsible Party: Godfrey Pearlson, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT03191084     History of Changes
Other Study ID Numbers: HHC-2016-0261
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Godfrey Pearlson, Yale University:
marijuana
THC
cannabis
driving
impairment
intoxication

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders