Recruiting
Phase 1

SpotLight-THC

Sponsor:

ISBRG Corp

Code:

NCT05276232

Conditions

Cannabis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cannabis(THC) inhaled

Study Details

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.

Conditions

Cannabis

Study ID

NCT05276232

Start date

Mar, 2022

Status verified date

Feb, 2022

Completion date

Aug, 2022

Anticipated

Primary completion date

Aug, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Baseline followed by 5-10% THC Validation

experimental: Baseline followed by 5-10% THC Verification

Interventions

Cannabis(THC) inhaled

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

Primary outcome measure

  • Change in Acute Subjective Response to Cannabis Score [ Time Frame: At baseline, 20, 30, 60, 90, 120 and 180 minutes ]

Central Contacts and Locations

Central contacts

Rose A Schmitt, B.S.

319-335-4666rose-potter@uiowa.edu

Timothy L Brown, Ph.D.

319-335-4785timothy-l-brown@uiowa.edu

Locations

National Advanced Driving Simulator

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Rose A Schmitt, B.S.

319-335-4666rose-potter@uiowa.edu

Timothy L Brown, Ph.D.

319-335-4785timothy-l-brown@uiowa.edu

Principal Investigator:

Timothy L Brown, Ph.D.

More Information

Sponsor

ISBRG Corp

Last update posted

Mar 11, 2022

Last verified

Feb, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ISBRG Corp on 2022-03-11.