Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorJohns Hopkins University
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
(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,
Trial design
Design model
Crossover
Treatments tested in this trial
Cannabis
Drugcannabis with 0, 5, or 30 mg THC will be inhaled via vaporization
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: 0 mg THCPlacebo comparator 1 intervention
Group B: 5 mg THCExperimental treatment 1 intervention
Group C: 30 mg THCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
pre-administration, post-administration, 2, 4 hours2
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.
Time frame
pre-administration, post-administration, 2, 4 hours3
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.
Time frame
pre-administration, post-administration, 2, 4 hours4
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.
Time frame
pre-administration, post-administration, 2, 4 hoursSecondary outcomes
1
Saccade Speed
Measures how quickly participants look back and forth between two spots as possible during the oculomotor task.
Time frame
Pre-administration, post-administration, 2, 4 hours2
Visually Guided Oculomotor Performance
Measures how quickly and accurately participants move their eyes to a cue as soon as it appears on the oculomotor task.
Time frame
Pre-administration, post-administration, 2, 4 hours3
Antisaccade
Measures voluntary eye movement in the direction opposite to the side in which a visual cue is presented.
Time frame
Pre-administration, post-administration, 2, 4 hours4
Memory-Guided
Measures how quickly gaze is shifted directly and accurately to a remembered cue position.
Time frame
Pre-administration, post-administration, 2, 4 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov
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