Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cannabis.
- Who it may be relevant to
- Registry conditions: Cannabis Use, Impaired Driving, Cognitive Impairment. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Cannabis
cannabis with 0, 5, or 30 mg THC will be inhaled via vaporization
Primary outcome measures
- Commission Errors [Time frame: pre-administration, post-administration, 2, 4 hours]
- Omission Errors [Time frame: pre-administration, post-administration, 2, 4 hours]
- Reaction Time [Time frame: pre-administration, post-administration, 2, 4 hours]
- Reaction Time Standard Error [Time frame: pre-administration, post-administration, 2, 4 hours]
- Visuomotor Index [Time frame: pre-administration, post-administration, 2, 4 hours]
Secondary outcome measures (4)
- Saccade Speed [Time frame: Pre-administration, post-administration, 2, 4 hours]
- Visually Guided Oculomotor Performance [Time frame: Pre-administration, post-administration, 2, 4 hours]
- Antisaccade [Time frame: Pre-administration, post-administration, 2, 4 hours]
- Memory-Guided [Time frame: Pre-administration, post-administration, 2, 4 hours]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Johns Hopkins Behavioral Pharmacology Research Unit — Baltimore
Identifiers
NCT: NCT06351540 · IRB00332797 · R21DA056687