CannabisPhase 1NCT05276232
Detection of Cannabis Impairment With ISBRG's SpotLight-THC
A Phase 1 study testing Cannabis(THC) inhaled in people with Cannabis, run by ISBRG Corp at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis
- What is being tested?
- Cannabis(THC) inhaled
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2022to Aug 2022
- Phase
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Advanced Driving Simulator
Iowa City, Iowa, 52242
Rose A Schmitt, B.S., 319-335-4666, rose-potter@uiowa.edu
Timothy L Brown, Ph.D., 319-335-4785, timothy-l-brown@uiowa.edu
About this study
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.
Read the 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.
- Conditions
- Cannabis
- Being tested
- Cannabis(THC) inhaled
- Keywords
- Driving under the influence, Cannabis impairment, SpotLight-THC, Non-invasive detection, THC, ISBRG
- Medical subject headings
- Marijuana Abuse, Driving Under the Influence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis(THC) inhaledDrug
Cannabis vapor is produced from 500mg, approximately 5-10% High dose bulk cannabis plant material, 30-37.5 mg THC
| Study group | Role | What they receive |
|---|---|---|
| Baseline followed by 5-10% THC Validation | Experimental | Not described Receives: Drug: Cannabis(THC) inhaled |
| Baseline followed by 5-10% THC Verification | Experimental | Not described Receives: Drug: Cannabis(THC) inhaled |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, 20, 30, 60, 90, 120 and 180 minutes
Secondary outcomes (3)
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.
Measured: Over a 20 minute drive conducted at 30, 90 and 180 minutes post 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.
Measured: Over a 20 minute drive conducted at 30, 90 and 180 minutes post dose
Blood Delta-9-THC
THC concentration levels of Delta-9-THC in whole blood.
Measured: At baseline, 20, 90, and 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISBRG Corp
- Sponsor type
- University, hospital or other
- Collaborators
- National Advanced Driving Simulator
- Responsible party
- Sponsor
- Investigators
- Timothy L Brown, Ph.D., Principal investigator, National Advanced Driving Simulator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276232
- Sponsor's protocol ID
- 202108451
- Status last verified
- Feb 2022
- First submitted
- 11 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Cannabis Impairment With ISBRG's SpotLight-THC
- ClinicalTrials.gov ID
- NCT05276232
- Acronym / sponsor ID
- 202108451
- Conditions
- Cannabis
- Keywords
- Driving under the influence, Cannabis impairment, SpotLight-THC, Non-invasive detection, THC, ISBRG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- ISBRG CorpUniversity, hospital or other
- Collaborators
- National Advanced Driving Simulator
- Study start
- Mar 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 11 Mar 2022 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline followed by 5-10% THC Validation | Experimental | Drug: Cannabis(THC) inhaled |
| Baseline followed by 5-10% THC Verification | Experimental | Drug: Cannabis(THC) inhaled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
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 |
|---|---|---|
| Cannabis(THC) inhaledCannabis vapor is produced from 500mg, approximately 5-10% High dose bulk cannabis plant material, 30-37.5 mg THC | Drug | Baseline followed by 5-10% THC Validation, Baseline followed by 5-10% THC Verification |
Primary outcome
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.
3 secondary outcomes
Standard Deviation of Lateral Position (SDLP) - Undistracted
Time frame: 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
Blood Delta-9-THC
Time frame: At baseline, 20, 90, and 180 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- 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.
Timothy L Brown, Ph.D. principal investigator
National Advanced Driving Simulator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabis(THC) inhaled in people with Cannabis, run by ISBRG Corp at 1 site in United States.
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 21 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: status not confirmed, as of the sponsor's last update on 11 Mar 2022. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rose A Schmitt, B.S. (319-335-4666, rose-potter@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Acute Subjective Response to Cannabis Score (time frame: At baseline, 20, 30, 60, 90, 120 and 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2022.