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NCT04100590 · ClinicalTrials.gov registry record · Phase 2

Eye Tracking as a Biomarker of Cannabis Effects

A Phase 2 study, sponsored by New York State Psychiatric Institute.

Terminated
Registry status
Phase 2
Development phase
1
Enrollment target

NCT04100590: Clinical Trial Phase 2 study, sponsored by New York State Psychiatric Institute.

NCT04100590 is a Phase 2 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04100590, a Phase 2 study, was terminated before completion, sponsored by New York State Psychiatric Institute.

TERMINATED
Registry status
Phase 2
Development phase
1 participants
Enrollment target

Study 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, 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). 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 (th

Primary Outcome

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 t

Interventions

  • DRUG Cannabis

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2019-10-01
Est. Completion 2020-01-31
Phase Phase 2

Why NCT04100590 stopped before completion

NCT04100590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Cannabis is the first listed.

NCT04100590 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04100590 about?

NCT04100590 is a clinical study titled "Eye Tracking as a Biomarker of Cannabis Effects". 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 ...

What is the current status of trial NCT04100590?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2019-10-01. Estimated completion is 2020-01-31.

What interventions are being tested in trial NCT04100590?

The interventions under investigation include: Cannabis (DRUG).

Who is sponsoring clinical trial NCT04100590?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04100590's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04100590, the US trial registry maintained by the National Library of Medicine. NCT04100590 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.