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NCT Number: NCT06351540

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

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.

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Key information

Conditions

Cannabis Use Chemically-Induced Disorders Cognition Disorders Cognitive Dysfunction Cognitive Impairment Impaired Driving Marijuana Abuse Mental Disorders Neurocognitive Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria: Healthy non-treatment seeking adults (age 18 to 60, N = 40) who report
  • (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.

Treatment and study plan

Cannabis

Drug

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

Primary outcomes

  1. Commission Errors

    Time frame: pre-administration, post-administration, 2, 4 hours

    The Conners Continuous Performance Test (CPT) will be used to assess sustained attention. Commission errors is measured by calculating the number of trials participants incorrectly push the spacebar in the presence of "X" stimulus.

  2. Omission Errors

    Time frame: pre-administration, post-administration, 2, 4 hours

    The Conners Continuous Performance Test (CPT) will be used to assess sustained attention. Omission errors is measured by calculating the number of trials participants fail to push the spacebar in the presence of a letter that is not an "X" stimulus.

  3. Reaction Time

    Time frame: pre-administration, post-administration, 2, 4 hours

    The Conners Continuous Performance Test (CPT) will be used to assess sustained attention. Reaction time is measured by calculating the duration between the presentation of a letter other than "X", and the correct response of a spacebar push.

  4. Reaction Time Standard Error

    Time frame: pre-administration, post-administration, 2, 4 hours

    The Conners Continuous Performance Test (CPT) will be used to assess sustained attention. Reaction time standard error is measured by calculating the standard error of the mean of the reaction time.

  5. Visuomotor Index

    Time frame: pre-administration, post-administration, 2, 4 hours

    The visuomotor index score is calculated by mathematically integrating five measures of oculomotor fixation performance and two measures of accuracy into a single score during fixation and accuracy tasks, respectively. Test of visual fixation to measure microsaccades, spontaneous nystagmus, and gaze-evoked nystagmus.

Secondary outcomes

  1. Saccade Speed

    Time frame: Pre-administration, post-administration, 2, 4 hours

    Measures how quickly participants look back and forth between two spots as possible during the oculomotor task.

  2. Visually Guided Oculomotor Performance

    Time frame: Pre-administration, post-administration, 2, 4 hours

    Measures how quickly and accurately participants move their eyes to a cue as soon as it appears on the oculomotor task.

  3. Antisaccade

    Time frame: Pre-administration, post-administration, 2, 4 hours

    Measures voluntary eye movement in the direction opposite to the side in which a visual cue is presented.

  4. Memory-Guided

    Time frame: Pre-administration, post-administration, 2, 4 hours

    Measures how quickly gaze is shifted directly and accurately to a remembered cue position.

Study contacts

Contact information is provided by the study sponsor or research team.

Dustin C Lee, PhD

CONTACT

[email protected]

410-550-4035

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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