Examine the Feasibility of a Standardized Field Test for Marijuana Impairment: Laboratory Evaluations
Condition: Marijuana Impairment
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Early Phase 1

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.)
    

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
    

Intervention name(s): Low Dose THC Marijuana; High Dose THC Marijuana; Placebo Marijuana
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dosing via vaporized marijuana using a lower concentration of THC, participants receive this dose on two of the five study visits.; Dosing via vaporized marijuana using a higher concentration of THC, participants receive this dose on two of the five study visits.; Dosing via vaporized marijuana with no THC, participants receive this dose on one of the five study visits.
Other intervention name(s): THC, Cannabis; THC, Cannabis; THC, Cannabis
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: marijuana; THC; cannabis; driving; impairment; intoxication