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Cannabis UsePhase 2NCT04100590

Eye Tracking as a Biomarker of Cannabis Effects

A Phase 2 study testing Cannabis in people with Cannabis Use and Pain, Acute, run by New York State Psychiatric Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Biomarkers of recent drug use and intoxication have societal relevance, in that they are used by law enforcement and other agencies to detect drug impairment. For instance, a breathalyzer can quickly and accurately detect blood alcohol content (BAC) to indicate if a person is under the influence of alcohol; however… Read more about this study

Who is it for?
Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Cannabis Use, Pain, Acute
What is being tested?
Cannabis
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1 participants
Where
1 siteUnited States
Study dates
1 Oct 2019to 31 Jan 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males/non-pregnant females
  • Report smoking cannabis ≥1 day per week
  • Able to perform all study procedures

Who cannot join

  • Meeting DSM-V criteria for severe substance use
  • Use of illicit drugs ≥1 day/week in the prior 4 weeks
  • Abnormality with the eyes which may affect the eye tracking technology such as color blindness, naturally occurring nystagmus, amblyopia, strabismus, age-related macular degeneration (AMD), cataract, diabetic eye disease, glaucoma, dry eye, extreme refractive error, bacterial or viral infections of the eye
  • 7. User of supplemental oxygen

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New York State Psychiatric Institute

    New York, New York, 10032

Other trials in United States

About this study

Biomarkers of recent drug use and intoxication have societal relevance, in that they are used by law enforcement and other agencies to detect drug impairment. For instance, a breathalyzer can quickly and accurately detect blood alcohol content (BAC) to indicate if a person is under the influence of alcohol; however, there is currently no similar way to quickly detect if a person is under the influence of cannabis. In light of increasing cannabis use, it is important to define a quantitative, objective method of determining recent use and intoxication.

The link between changes in eye characteristics (e.g. movement, pupil dilation) and cannabis use is documented (Peragallo et al. 2013), but insufficiently characterized. Certain outcomes of eye behavior are known to be affected by recent cannabis use (e.g. the eyes' ability to converge on a target; Stapleton et al 1986), while findings are mixed regarding other outcomes (e.g. the eyes' ability to smoothly follow a target; Fant et al. 1998). Thus, the goal of this study is to identify a characteristic pattern of eye behavior, defined by performance on a battery of four eye tasks, as a function of recent cannabis use (7% vs. 0% THC).

Read more

Using 30 healthy cannabis users (15 men, 15 women), this study will be one of the first to assess changes in eye behavior as a function of recent cannabis use within a quantified virtual reality (VR) environment. This study will examine the effect of smoked cannabis (7% vs. 0% THC) on individual eye movements, with the goal of defining the utility of the eyes as potential objective indicators of cannabis use and intoxication. Four eye tests (nystagmus, smooth pursuit, convergence, and pupillary light response; outlined below), which previous literature has defined as effective in detecting recent drug use (including opioids and alcohol; Murillo et al. 2004), have been compiled into a 5-minute task battery using a VR headset environment equipped with high frequency infrared eye trackers (the HTC Vive with Pupil Labs Tracking). This 5-minute VR battery of four eye tests will be administered prior to cannabis consumption as a baseline, and then at 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 min after cannabis, with the goal of comparing baseline values to the ten post-cannabis timepoints to detect changes in eye behavior as a function of cannabis intoxication. The study will also utilize a battery of subjective-effects and mood visual analogue scales (0-100 mm; e.g. 'Good Drug Effect') prior to the eye test battery at each timepoint, allowing us to correlate each outcome of the eye tasks to subjectively reported cannabis impairment and mood.

In addition to measuring eye behavior as a function of cannabis use, the training session of this study will be used to also collect exploratory data on the relationship between pupil dilation and experimental pain. Using Quantitative Sensory Testing (Medoc TSA-II NeuroSensory Analyzer), thermal pain threshold and tolerance will be induced using a cold stimulus (4.0°C; induced with a 30 x 30 mm Peltier thermode, which is 1.5" square metal applicator that is connected to the TSA-II NeuroSensory Analyzer device and software, and produces an ongoing cold sensation applied to the lower palm of the participant's non-dominant hand). Participants will indicate first feelings of pain (pain threshold), and when the pain becomes too much to bear (pain tolerance) by pressing a button on a controller connected to the TSA-II. Throughout exposure to the cold stimulus, changes in pupil size to the patient's subjectively reported pain latencies will be recorded.

Being tested
Cannabis
Medical subject headings
Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CannabisDrug

    Smoked active cannabis (7% THC) vs. placebo inactive cannabis (0% THC)

Study groups in NCT04100590
Study groupRoleWhat they receive
Active CannabisExperimentalIn this session, the participant will smoke two-thirds of one active cannabis cigarette (7% THC) according to our paced-puff procedure (Foltin et al. 1987). They will complete an eye task battery (5 minutes per battery) 15 minutes prior to smoking as a baseline measure in each session, and again at the following timepoints: 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis. Baseline assessments will be compared to those at post-cannabis timepoints.
Receives: Drug: Cannabis
Placebo CannabisPlacebo comparatorIn this session, the participant will smoke two-thirds of one inactive placebo cannabis cigarette (0% THC) according to our paced-puff procedure (Foltin et al. 1987). They will complete an eye task battery (5 minutes per battery) 15 minutes prior to smoking as a baseline measure in each session, and again at the following timepoints: 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis. Baseline assessments will be compared to those at post-cannabis timepoints.
Receives: Drug: Cannabis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Convergence

    Using a Virtual Reality headset, a stimulus (a fixation cross) moves from 12 inches to 2 inches away from the participant's nose at a continuous speed over 5 seconds, then is held at that point for 10 seconds. The accuracy with which the participant completes this task will be measured by comparing pupil position with the target position within the virtual reality environment, down to the millimeter. Speed will also be assessed by measuring pupil position as a function of target fixation, down to the millisecond.

    Measured: % Change from baseline during each of two sessions (measurements taken at baseline, 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2019
  2. Study start1 Oct 2019
  3. Primary completion30 Dec 2019
  4. Study completion31 Jan 2020

Why it stopped: During a piloting phase with our staff, the technology/eye-tracking device did not collect outcomes as expected.

Resources

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 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Each volunteer will participate in two sessions in a cross-over fashion (active cannabis vs. inactive placebo cannabis)
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04100590
Sponsor's protocol ID
7844
Status last verified
Jun 2022
First submitted
19 Sep 2019
Last updated
30 Jun 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: De-identified eye-behavior data will be available to other researchers.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cannabis in people with Cannabis Use and Pain, Acute, run by New York State Psychiatric Institute 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 30 Jun 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Convergence (time frame: % Change from baseline during each of two sessions (measurements taken at baseline, 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis)). 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 30 Jun 2022.

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