Cannabis UsePhase 1NCT06351540
Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance
A Phase 1 study testing Cannabis in people with Cannabis Use and Impaired Driving, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, Impaired Driving, Cognitive Impairment
- What is being tested?
- Cannabis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- (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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
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
- Being tested
- Cannabis
- Keywords
- cannabis, THC, impairment
- Medical subject headings
- Cognitive Dysfunction, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
cannabis with 0, 5, or 30 mg THC will be inhaled via vaporization
| Study group | Role | What they receive |
|---|---|---|
| 0 mg THC | Placebo comparator | Inhaled Cannabis - 0 mg THC Receives: Drug: Cannabis |
| 5 mg THC | Experimental | Inhaled cannabis - 5 mg THC Receives: Drug: Cannabis |
| 30 mg THC | Experimental | Inhaled cannabis - 30 mg THC Receives: Drug: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-administration, post-administration, 2, 4 hours
Secondary outcomes (4)
Saccade Speed
Measures how quickly participants look back and forth between two spots as possible during the oculomotor task.
Measured: Pre-administration, post-administration, 2, 4 hours
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.
Measured: Pre-administration, post-administration, 2, 4 hours
Antisaccade
Measures voluntary eye movement in the direction opposite to the side in which a visual cue is presented.
Measured: Pre-administration, post-administration, 2, 4 hours
Memory-Guided
Measures how quickly gaze is shifted directly and accurately to a remembered cue position.
Measured: Pre-administration, post-administration, 2, 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double-blind, placebo-controlled, within-subjects crossover design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Dustin C Lee, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351540
- Sponsor's protocol ID
- IRB00332797
- Other IDs
- R21DA056687
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance
- ClinicalTrials.gov ID
- NCT06351540
- Acronym / sponsor ID
- IRB00332797
- Conditions
- Cannabis Use, Impaired Driving, Cognitive Impairment
- Keywords
- cannabis, THC, impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- double-blind, placebo-controlled, within-subjects crossover design
| Arm | Type | Receives |
|---|---|---|
| 0 mg THC | Placebo comparator | Drug: CannabisInhaled Cannabis - 0 mg THC |
| 5 mg THC | Experimental | Drug: CannabisInhaled cannabis - 5 mg THC |
| 30 mg THC | Experimental | Drug: CannabisInhaled cannabis - 30 mg THC |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- (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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabiscannabis with 0, 5, or 30 mg THC will be inhaled via vaporization | Drug | 0 mg THC, 30 mg THC, 5 mg THC |
Primary outcome
Commission Errors
Time frame: pre-administration, post-administration, 2, 4 hours
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.
Omission Errors
Time frame: pre-administration, post-administration, 2, 4 hours
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.
Reaction Time
Time frame: pre-administration, post-administration, 2, 4 hours
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.
Reaction Time Standard Error
Time frame: pre-administration, post-administration, 2, 4 hours
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.
Visuomotor Index
Time frame: pre-administration, post-administration, 2, 4 hours
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dustin C Lee, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabis in people with Cannabis Use and Impaired Driving, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dustin C Lee, PhD (410-550-4035, dlee214@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Commission Errors (time frame: pre-administration, post-administration, 2, 4 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.