Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance

NCT ID: NCT06351540

Last Updated: 2026-01-30

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

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2026-07-01

Brief Summary

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The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users.

Detailed Description

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Conditions

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Cannabis Use Impaired Driving Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

double-blind, placebo-controlled, within-subjects crossover design
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
placebo controlled, double-blind

Study Groups

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0 mg THC

Inhaled Cannabis - 0 mg THC

Group Type PLACEBO_COMPARATOR

Cannabis

Intervention Type DRUG

cannabis with 0, 5, or 30 mg THC will be inhaled via vaporization

5 mg THC

Inhaled cannabis - 5 mg THC

Group Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

cannabis with 0, 5, or 30 mg THC will be inhaled via vaporization

30 mg THC

Inhaled cannabis - 30 mg THC

Group Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

cannabis with 0, 5, or 30 mg THC will be inhaled via vaporization

Interventions

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Cannabis

cannabis with 0, 5, or 30 mg THC will be inhaled via vaporization

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* (a) infrequent cannabis use defined as at least one reported use in the past year with a negative THC urine toxicology at baseline, or
* (b) report frequent cannabis use defined as \> 5 days per week for \> 1 year with a positive THC urine toxicology at baseline.

These criteria were selected to target individuals with low and high-frequency cannabis use in order to examine the direct effect of tolerance on study outcome measures.

Exclusion Criteria

* (1) meet DSM-V criteria for substance use disorders other than tobacco, cannabis, or caffeine,
* (2) are currently receiving or interested in immediately receiving behavioral treatment or medication for cannabis cessation,
* (3) current use of any medications that could affect study outcomes,
* (4) test positive for drugs of abuse (other than cannabis) and/or breath alcohol test at study admission,
* (5) have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity,
* (6) are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding,
* (7) have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina), or (8) are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dustin C Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Site Status

Countries

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United States

Central Contacts

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Dustin C Lee, PhD

Role: CONTACT

410-550-4035

Other Identifiers

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R21DA056687

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00332797

Identifier Type: -

Identifier Source: org_study_id

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