Clinical trial NCT06351540: Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance
Official title: Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Cannabis Use
Impaired Driving
Cognitive Impairment
Keywords: cannabis
THC
impairment
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: double-blind, placebo-controlled, within-subjects crossover design
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Commission Errors
timeFrame: pre-administration, post-administration, 2, 4 hours
measure: Omission Errors
timeFrame: pre-administration, post-administration, 2, 4 hours
measure: Reaction Time
timeFrame: pre-administration, post-administration, 2, 4 hours
measure: Reaction Time Standard Error
timeFrame: pre-administration, post-administration, 2, 4 hours
measure: Visuomotor Index
timeFrame: pre-administration, post-administration, 2, 4 hours
Secondary outcomes:
measure: Saccade Speed
timeFrame: Pre-administration, post-administration, 2, 4 hours
measure: Visually Guided Oculomotor Performance
timeFrame: Pre-administration, post-administration, 2, 4 hours
measure: Antisaccade
timeFrame: Pre-administration, post-administration, 2, 4 hours
measure: Memory-Guided
timeFrame: Pre-administration, post-administration, 2, 4 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dustin C Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: