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

NCT03191084 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: 2000021338DTNH2216C00022
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.)

Conditions

Marijuana Impairment

Keywords

marijuana; THC; cannabis; driving; impairment; intoxication

Outcome Measures

Primary Outcomes (13)

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

  The Cogstate 1-back/2-back task assesses working memory, it will be administered prior to dosing and at various time points after dosing.

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

• Marijuana induced performance changes on Cogstate Card Learning.

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

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

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

  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.

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

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

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

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

• Marijuana induced performance changes on Alertmeter.

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

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

• Marijuana induced performance changes on the Time Estimation Task.

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

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

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

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

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

• Marijuana induced performance changes on the Critical Tracking Task.

  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.

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

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

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

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

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

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

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

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

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

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

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

  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.

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

• Marijuana induced performance changes on the Time Reproduction Task.

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

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

Secondary Outcomes (6)

• Change in concentration of THC/metabolites in blood samples.

  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.

• Change in concentration of THC/metabolites in oral fluid tested using Draeger Drug Detection Kits.

  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.

• Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.

  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.

• Change in performance on simulated driving Road Tracking Task.

  Post drug administration at: 1 hour, 3 hours and 5 hours

• Change in performance on simulated driving Car Following Task.

  Post drug administration at: 1 hour, 3 hours and 5 hours

Study Arms (2)

Regular Users

EXPERIMENTAL

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; Drug: High Dose THC Marijuana; Drug: Placebo Marijuana

Occasional Users

EXPERIMENTAL

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; Drug: High Dose THC Marijuana; Drug: Placebo Marijuana

Interventions

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.

Also known as: THC, Cannabis

Occasional Users; Regular Users

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.

Also known as: THC, Cannabis

Occasional Users; Regular Users

Placebo Marijuana DRUG

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

Also known as: THC, Cannabis

Occasional Users; Regular Users

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Olin Neuropsychiatry Research Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol; nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: December 1, 2017
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

US (1)