Cannabis IntoxicationEarly Phase 1NCT03994926

Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment

A Early Phase 1 study testing Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-Eye and Cannabis cigarette - 4.0% THC in people with Cannabis Intoxication, run by Battelle Memorial 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

The purpose of this study is to determine if an eye tracking impairment sensor can detect cannabis-induced impairment after using cannabis.The overall objective is to correlate measures collected from the eye tracking sensor with measures related to cannabis impairment (e.g., plasma THC levels, self-reported cannabis… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Cannabis Intoxication
What is being tested?: Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-Eye and Cannabis cigarette - 4.0% THC
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: 3 Feb 2020to 13 Mar 2020
Phase: Early Phase 1
Are there results?: None posted in the registry

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Willing to sign a confidentiality agreement stating the will not discuss study specifics, information or materials presented to them in the study with those not involved in the study;
Currently living in Baltimore City or Baltimore County, MD, or Investigator discretion;
Able to read, understand, and sign informed consent;
18-55 years old;
Self-reports lifetime smoking of cannabis at least 10 times without any negative side effects;
Self-reports past-year smoking of cannabis at least 1 time but no more than 2 days per week on average;
Designation of Medically Healthy for Research by the Study Physician.
Agree to abstain from consuming alcohol for 10 hours and marijuana for 72 hour prior to the study visit

Who cannot join

BAC > 0.020% as measured by alcohol breathalyzer;
Meets DSM-5 criteria for any current Axis I disorder other than mild or moderate Cannabis Use Disorder;
Self-reported current desire to stop cannabis use, defined as 7 or greater on an 11-rung (scale of 0-10) on the Contemplation Ladder assessment;
Self-reported current asthma, chronic obstructive pulmonary disease, hypertension, cardiovascular disease or any other medical illness that precludes participation based on the clinical judgment of the Study Physician and Investigative Team;
Has difficulties with blood draws or poor venous access;
History of blood donation in the past 30 days or receiving blood products within the past 2 months prior to any experimental visit;

Show all 16Show fewer

Investigator discretion due to self-reported use of medical cannabis or using cannabis for self-medication;
Among females, current pregnancy or lactation or attempting to get pregnant, or at risk of becoming pregnant, as defined as being sexually active with a male partner and not willing to use a reliable form of contraception;
Investigator discretion due to use of caffeine, over-the-counter (OTC) drugs, prescription drugs, alcohol, or physical/mental health history;
Positive urine drug screen for drugs included on the urine drug panel other than cannabis;
Acute illness (such as cold or flu) which will require participant to be rescheduled, if authorized by study PI;
Vital signs thought to be clinically significant by licensed medical professional;
Self-reported history or medical evidence of prior intravenous drug use; and
Investigator discretion due to medical, mental health, or substance use history.
Presence of implanted devices in the body (pacemaker etc)
Previously reported negative effects from the use of VR goggles or negative effects from the use of VR goggles during screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Battelle Memorial Institute
Baltimore, Maryland, 21209

Other trials in United States

About this study

Read the detailed description

The proposed project is a single-visit clinical laboratory study to evaluate the initial efficacy of an eye tracking sensor to detect cannabis-related impairment.

Participants will be experienced but not frequent cannabis users without evidence of heavy alcohol or illicit drug use or other physical or mental health illness. Participants will come in for one screening visit, and those who consent, are eligible, and enroll will complete one experimental laboratory session involving smoking of 50% of 1 active (approximately 4.0% THC) cannabis cigarette. Assessments will be collected after-cannabis smoking up to 4 hours. Participants will be sent home from the laboratory via taxi.

Conditions: Cannabis Intoxication
Being tested: Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-Eye, Cannabis cigarette - 4.0% THC
Keywords: cannabis
Medical subject headings: Marijuana Abuse

What participants receive

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

Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-EyeDevice
Device measures smooth eye pursuit and response to light flash after pt smokes cannabis
Cannabis cigarette - 4.0% THCDrug
Also called Marijuana
smoked cannabis 4.0% THC

Study groups in NCT03994926
Study group	Role	What they receive
Experimental	Experimental	Directed smoking of about 3.6% THC cannabis cigarette Receives: Device: Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-Eye; Drug: Cannabis cigarette - 4.0% THC

What is being measured

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

Change from baseline in Pupil Dilation
Change in pupil dilation in different lights will be measured by the eye tracking sensor
Measured: Before and after smoking (up to 240 minutes)
Change from baseline in Gaze Nystagmus
Change in Gaze Nystagmus will be measured by the eye tracking sensor
Measured: Before and after smoking (up to 240 minutes)
Change from baseline in Lack of Convergence
Change in Lack of Convergence will be measured by the eye tracking sensor
Measured: Before and after smoking (up to 240 minutes)

Secondary outcomes (4)

Plasma THC
Plasma concentration before and after smoking
Measured: Before and after smoking (9 timepoints up to 240 minutes post smoking)
Change from baseline in Cannabis Subjective Effects
Scores for the question "do you feel a drug effect" are measured on a 0-100 point visual analogue scale to measure change in marijuana intoxication across timepoints.
Measured: Before and after smoking (up to 240 minutes post smoking)
Change from baseline in Four Choice Reaction Time Task
Will assess changes in psychomotor/cognitive performance known to be sensitive to the acute effects of smoked cannabis.
Measured: Before and after smoking (up to 240 minutes post smoking)
Change from baseline in Digit Symbol Substitution Task
Will assess changes in psychomotor/cognitive performance known to be sensitive to the acute effects of smoked cannabis.
Measured: Before and after smoking (up to 240 minutes post smoking)

Timeline

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

3 Feb 202013 Mar 2020

First posted21 Jun 2019
Study start3 Feb 2020
Primary completion13 Mar 2020
Study completion13 Mar 2020

Why it stopped: COVID-19 Pandmic halted study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Cannabis IntoxicationStudies of the same condition, open and under way.
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: Early Phase 1
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03994926
Sponsor's protocol ID: 131310
Status last verified: Sep 2021
First submitted: 12 Jun 2019
Last updated: 1 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Casswell S, Marks D. Cannabis induced impairment of performance of a divided attention task. Nature. 1973 Jan 5;241(5384):60-1. doi: 10.1038/241060b0. No abstract available.
PubMed 4696937
Desrosiers NA, Ramaekers JG, Chauchard E, Gorelick DA, Huestis MA. Smoked cannabis' psychomotor and neurocognitive effects in occasional and frequent smokers. J Anal Toxicol. 2015 May;39(4):251-61. doi: 10.1093/jat/bkv012. Epub 2015 Mar 4.
PubMed 25745105
Murillo R, Crucilla C, Schmittner J, Hotchkiss E, Pickworth WB. Pupillometry in the detection of concomitant drug use in opioid-maintained patients. Methods Find Exp Clin Pharmacol. 2004 May;26(4):271-5.
PubMed 15319805
Pickworth WB, Rohrer MS, Fant RV. Effects of abused drugs on psychomotor performance. Exp Clin Psychopharmacol. 1997 Aug;5(3):235-41. doi: 10.1037//1064-1297.5.3.235.
PubMed 9260070

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of an Eye Tracking Sensor to Detect Cannabis Impairment
ClinicalTrials.gov ID: NCT03994926
Acronym / sponsor ID: 131310
Conditions: Cannabis Intoxication
Keywords: cannabis
Phase: Early Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: COVID-19 Pandmic halted study
Enrolment: 3 participants (actual)
Lead sponsor: Battelle Memorial InstituteUniversity, hospital or other
Study start: 3 Feb 2020 (actual)
Primary completion: 13 Mar 2020 (actual)
Study completion: 13 Mar 2020 (actual)
First posted: 21 Jun 2019 (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.

Detailed description

The proposed project is a single-visit clinical laboratory study to evaluate the initial efficacy of an eye tracking sensor to detect cannabis-related impairment.

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental	Experimental	Device: Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-Eye, Drug: Cannabis cigarette - 4.0% THCDirected smoking of about 3.6% THC cannabis cigarette

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Willing to sign a confidentiality agreement stating the will not discuss study specifics, information or materials presented to them in the study with those not involved in the study;
Currently living in Baltimore City or Baltimore County, MD, or Investigator discretion;
Able to read, understand, and sign informed consent;
18-55 years old;
Self-reports lifetime smoking of cannabis at least 10 times without any negative side effects;

Key exclusion criteria (16 listed)

BAC > 0.020% as measured by alcohol breathalyzer;
Meets DSM-5 criteria for any current Axis I disorder other than mild or moderate Cannabis Use Disorder;
Self-reported current desire to stop cannabis use, defined as 7 or greater on an 11-rung (scale of 0-10) on the Contemplation Ladder assessment;
Self-reported current asthma, chronic obstructive pulmonary disease, hypertension, cardiovascular disease or any other medical illness that precludes participation based on the clinical judgment of the Study Physician and Investigative Team;
Has difficulties with blood draws or poor venous access;

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
Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-EyeDevice measures smooth eye pursuit and response to light flash after pt smokes cannabis	Device	Experimental
Cannabis cigarette - 4.0% THCAlso: Marijuanasmoked cannabis 4.0% THC	Drug	Experimental

Primary outcome

Change from baseline in Pupil Dilation
Time frame: Before and after smoking (up to 240 minutes)
Change in pupil dilation in different lights will be measured by the eye tracking sensor
Change from baseline in Gaze Nystagmus
Time frame: Before and after smoking (up to 240 minutes)
Change in Gaze Nystagmus will be measured by the eye tracking sensor
Change from baseline in Lack of Convergence
Time frame: Before and after smoking (up to 240 minutes)
Change in Lack of Convergence will be measured by the eye tracking sensor

4 secondary outcomes

Plasma THC
Time frame: Before and after smoking (9 timepoints up to 240 minutes post smoking)
Change from baseline in Cannabis Subjective Effects
Time frame: Before and after smoking (up to 240 minutes post smoking)
Change from baseline in Four Choice Reaction Time Task
Time frame: Before and after smoking (up to 240 minutes post smoking)
Change from baseline in Digit Symbol Substitution Task
Time frame: Before and after smoking (up to 240 minutes post smoking)

Results and safety

The study was stopped early (reason given: COVID-19 Pandmic halted study). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
Background: PubMed 4696937Casswell S, Marks D. Cannabis induced impairment of performance of a divided attention task. Nature. 1973 Jan 5;241(5384):60-1. doi: 10.1038/241060b0. No abstract available.
Background: PubMed 25745105Desrosiers NA, Ramaekers JG, Chauchard E, Gorelick DA, Huestis MA. Smoked cannabis' psychomotor and neurocognitive effects in occasional and frequent smokers. J Anal Toxicol. 2015 May;39(4):251-61. doi: 10.1093/jat/bkv012. Epub 2015 Mar 4.
Background: PubMed 15319805Murillo R, Crucilla C, Schmittner J, Hotchkiss E, Pickworth WB. Pupillometry in the detection of concomitant drug use in opioid-maintained patients. Methods Find Exp Clin Pharmacol. 2004 May;26(4):271-5.
Background: PubMed 9260070Pickworth WB, Rohrer MS, Fant RV. Effects of abused drugs on psychomotor performance. Exp Clin Psychopharmacol. 1997 Aug;5(3):235-41. doi: 10.1037//1064-1297.5.3.235.
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 16 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 1 Oct 2021. 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. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

The study was stopped early (reason given: COVID-19 Pandmic halted study). Results are not available in the source record.

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?

Change from baseline in Pupil Dilation (time frame: Before and after smoking (up to 240 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03994926, which also lists 4 linked publications.

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 1 Oct 2021.