Detection of Cannabis Impairment With ISBRG's SpotLight-THC

March 2, 2022 updated by: ISBRG Corp

Subjects will participate in a 2-visit study protocol in which they will be administered cannabis of pre-determined concentrations and asked to complete a simulated drive in a driving simulator. Subjects will be scanned on two SpotLight-THC (Alpha and Beta iterations) devices and peripheral venous whole blood will be collected from subjects for analysis on up to four occasions on each visit.

The purpose of the investigation will be to determine whether the SpotLight-THC device is a reliable measure of THC impairment at the roadside, with an objective to identify a unique blood analyte architecture for THC impairment using near infrared light and machine learning.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

At the University of Iowa, subjects who currently use cannabis recreationally will be recruited. They will then undergo a screening visit in which consent is obtained, questionnaires are given, a physical exam is conducted and subjects will use the driving simulator to assess propensity to sickness and to familiarize them with the simulation. They will then be scheduled for their next visit. At the second visit, subjects will be administered 5-10% THC. A series of baseline tests, including a test requiring a blood sample will be administered upon arrival. After drug administration, subjects will be asked to complete a set of verbal recall questions followed by three simulated driving trials, completing 7 non-invasive SpotLight-19 scans (20 seconds x 2) and 3 blood samples throughout the visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • National Advanced Driving Simulator
        • Contact:
        • Contact:
        • Principal Investigator:
          • Timothy L Brown, Ph.D.
        • Sub-Investigator:
          • Gary R Gaffney, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged at least 18 years old
  • Must self-report use of cannabis at least once a month
  • Has held a valid driver's license at least 12 months
  • Must be willing to abstain from using cannabis and alcohol for 24 hours prior to each session
  • Must be willing to abstain from all other drugs not medically required for duration of the study (beginning 24 hours prior to the screening visit)
  • Must be able to drive without special or non-standard equipment
  • Must be able to meet study time commitment
  • Provides written and informed consent

Exclusion Criteria:

  • Diagnosis of severe medical or psychiatric condition (as judged by study physician)
  • Evidence of substance use disorder as reflected by total scores on DUDIT and AUDIT
  • Regular user of medication that may affect cognitive functioning and/or driver performance (e.g., antidepressants, benzodiazepines, stimulants, opioids) as judged by study physician
  • Family history of schizophrenia or other psychotic disorder (or taking medications for such)
  • Pregnant or test positive for pregnancy, looking to become pregnant, or breastfeeding
  • Respiratory or pulmonary disorder that would negatively affect ability to inhale and hold the cannabis dose
  • Recent (past 6 months) head injury or stroke, or current symptoms from prior head injury or stroke
  • History of heart disease, angina, heart attack, heart surgery, or myocardial infarction (or taking medications for such)
  • Untreated/Untreatable vision or auditory issues (because testing currently requires both senses)
  • History of suicidal behaviors in past two years
  • Excessive tobacco use (more than 10 cigarettes a day or 3 or more cigars or pipes per day)
  • Excessive caffeine use (6 or more servings per day)
  • Excessive alcohol (14 or more drinks per week)
  • Regular use of pain medications other than OTC
  • Use of prescription drugs not prescribed to them or illicit drugs other than cannabis
  • History of substance abuse or substance addiction
  • Expressed interest in or participation in drug abuse treatment in past 60 days
  • Currently diagnosed cannabis use disorder
  • History of negative reaction to cannabis
  • Extreme scarring on fingertips that prevents use of the device
  • Participation in night shift work

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Baseline followed by 5-10% THC Validation
Drug: Cannabis(THC) inhaled
Cannabis vapor is produced from 500mg, approximately 5-10% High dose bulk cannabis plant material, 30-37.5 mg THC
Experimental: Baseline followed by 5-10% THC Verification
Drug: Cannabis(THC) inhaled
Cannabis vapor is produced from 500mg, approximately 5-10% High dose bulk cannabis plant material, 30-37.5 mg THC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Acute Subjective Response to Cannabis Score
Time Frame: At baseline, 20, 30, 60, 90, 120 and 180 minutes
The total score of the true responses (true/false scale, minimum score is 0 with a maximum score of 12). A higher score indicates greater drug effect. Used to determine subjective level of drug effect.
At baseline, 20, 30, 60, 90, 120 and 180 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Standard Deviation of Lateral Position (SDLP) - Undistracted
Time Frame: Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose
The ability to keep the vehicle straight in the lane and the corresponding data is presented from a rural drive without any secondary tasks relative to the 20 minute baseline drive pre dose.
Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose
Standard Deviation of Lateral Position (SDLP) - Distracted
Time Frame: Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose
The ability to keep the vehicle straight in the lane and the corresponding data is presented from a rural drive while engaged in a secondary task relative to the 20 minute baseline drive while engaged in the same task pre dose.
Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose
Blood Delta-9-THC
Time Frame: At baseline, 20, 90, and 180 minutes
THC concentration levels of Delta-9-THC in whole blood.
At baseline, 20, 90, and 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ISBRG Corp

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Advanced Driving Simulator

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Timothy L Brown, Ph.D., National Advanced Driving Simulator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202108451

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cannabis

Clinical Trials on Cannabis(THC) inhaled

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings