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

Johns Hopkins University

Status and phase: Begins enrollment this month; Phase 1

Conditions: Cognitive Impairment; Cannabis Use; Impaired Driving

Treatments: Drug: Cannabis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06351540

R21DA056687 (U.S. NIH Grant/Contract)

IRB00332797

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 3 patient groups, including a placebo group

0 mg THC

Placebo Comparator group

Description:

Inhaled Cannabis - 0 mg THC

Treatment:

Drug: Cannabis

5 mg THC

Experimental group

Description:

Inhaled cannabis - 5 mg THC

Treatment:

Drug: Cannabis

30 mg THC

Experimental group

Description:

Inhaled cannabis - 30 mg THC

Treatment:

Drug: Cannabis