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

NCT06351540 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB00332797R21DA056687
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis Use; Impaired Driving; Cognitive Impairment

Keywords

cannabis; THC; impairment

Outcome Measures

Primary Outcomes (5)

• Commission Errors

  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.

  pre-administration, post-administration, 2, 4 hours

• Omission Errors

  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.

  pre-administration, post-administration, 2, 4 hours

• Reaction Time

  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.

  pre-administration, post-administration, 2, 4 hours

• Reaction Time Standard Error

  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.

  pre-administration, post-administration, 2, 4 hours

• Visuomotor Index

  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.

  pre-administration, post-administration, 2, 4 hours

Secondary Outcomes (4)

• Saccade Speed

  Pre-administration, post-administration, 2, 4 hours

• Visually Guided Oculomotor Performance

  Pre-administration, post-administration, 2, 4 hours

• Antisaccade

  Pre-administration, post-administration, 2, 4 hours

• Memory-Guided

  Pre-administration, post-administration, 2, 4 hours

Study Arms (3)

0 mg THC

PLACEBO COMPARATOR

Inhaled Cannabis - 0 mg THC

Drug: Cannabis

5 mg THC

EXPERIMENTAL

Inhaled cannabis - 5 mg THC

Drug: Cannabis

30 mg THC

EXPERIMENTAL

Inhaled cannabis - 30 mg THC

Drug: Cannabis

Interventions

Cannabis DRUG

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

0 mg THC; 30 mg THC; 5 mg THC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

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

Study Officials

• Dustin C Lee, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dustin C Lee, PhD

CONTACT

410-550-4035; dlee214@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: placebo controlled, double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blind, placebo-controlled, within-subjects crossover design

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)