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Detection of Cannabis Impairment With ISBRG's SpotLight-THC

Primary Purpose

Cannabis

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cannabis(THC) inhaled

About this trial

This is an interventional basic science trial for Cannabis focused on measuring Driving under the influence, Cannabis impairment, SpotLight-THC, Non-invasive detection, THC, ISBRG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

National Advanced Driving SimulatorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Baseline followed by 5-10% THC Validation

Baseline followed by 5-10% THC Verification

Arm Description

Outcomes

Primary Outcome Measures

Change in Acute Subjective Response to Cannabis Score

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.

Secondary Outcome Measures

Standard Deviation of Lateral Position (SDLP) - Undistracted

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.

Standard Deviation of Lateral Position (SDLP) - Distracted

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.

Blood Delta-9-THC

THC concentration levels of Delta-9-THC in whole blood.

Full Information

NCT ID

NCT05276232

First Posted

February 11, 2022

Last Updated

March 2, 2022

Sponsor

ISBRG Corp

Collaborators

National Advanced Driving Simulator

1. Study Identification

Unique Protocol Identification Number

NCT05276232

Brief Title

Detection of Cannabis Impairment With ISBRG's SpotLight-THC

Official Title

Detection of Cannabis Impairment With ISBRG's SpotLight-THC

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 2022 (Anticipated)

Primary Completion Date

August 2022 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ISBRG Corp

Collaborators

National Advanced Driving Simulator

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cannabis

Keywords

Driving under the influence, Cannabis impairment, SpotLight-THC, Non-invasive detection, THC, ISBRG

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Baseline followed by 5-10% THC Validation

Arm Type

Experimental

Arm Title

Baseline followed by 5-10% THC Verification

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cannabis(THC) inhaled

Intervention Description

Cannabis vapor is produced from 500mg, approximately 5-10% High dose bulk cannabis plant material, 30-37.5 mg THC

Primary Outcome Measure Information:

Title

Change in Acute Subjective Response to Cannabis Score

Description

Time Frame

At baseline, 20, 30, 60, 90, 120 and 180 minutes

Secondary Outcome Measure Information:

Title

Standard Deviation of Lateral Position (SDLP) - Undistracted

Description

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.

Time Frame

Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose

Title

Standard Deviation of Lateral Position (SDLP) - Distracted

Description

Time Frame

Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose

Title

Blood Delta-9-THC

Description

THC concentration levels of Delta-9-THC in whole blood.

Time Frame

At baseline, 20, 90, and 180 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rose A Schmitt, B.S.

Phone

319-335-4666

rose-potter@uiowa.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Timothy L Brown, Ph.D.

Phone

319-335-4785

timothy-l-brown@uiowa.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy L Brown, Ph.D.

Organizational Affiliation

National Advanced Driving Simulator

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Advanced Driving Simulator

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rose A Schmitt, B.S.

Phone

319-335-4666

rose-potter@uiowa.edu

First Name & Middle Initial & Last Name & Degree

Timothy L Brown, Ph.D.

Phone

319-335-4785

timothy-l-brown@uiowa.edu

First Name & Middle Initial & Last Name & Degree

Timothy L Brown, Ph.D.

First Name & Middle Initial & Last Name & Degree

Gary R Gaffney, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Detection of Cannabis Impairment With ISBRG's SpotLight-THC

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