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

NCT ID: NCT03191084

Last Updated: 2024-07-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-03-30

Brief Summary

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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

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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

Conditions

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Marijuana Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Low Dose THC Marijuana

Intervention Type DRUG

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

High Dose THC Marijuana

Intervention Type DRUG

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

Placebo Marijuana

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Low Dose THC Marijuana

Intervention Type DRUG

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

High Dose THC Marijuana

Intervention Type DRUG

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

Placebo Marijuana

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Placebo Marijuana

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

Intervention Type DRUG

Other Intervention Names

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THC, Cannabis THC, Cannabis THC, Cannabis

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Highway Traffic Safety Administration (NHTSA)

FED

Sponsor Role collaborator

Hartford Hospital

OTHER

Sponsor Role collaborator

Montana State University

OTHER

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role collaborator

The Mind Research Network

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Godfrey Pearlson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Olin Neuropsychiatry Research Center

Hartford, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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DTNH2216C00022

Identifier Type: OTHER

Identifier Source: secondary_id

2000021338

Identifier Type: -

Identifier Source: org_study_id

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