Cannabis SmokingPhase 2NCT06059677
Cannabis Consumption and Driving Impairment Assessment on a Closed Course
A Phase 2 study testing Active smoked cannabis in people with Cannabis Smoking and Driving Impaired, run by Bayliss J. Camp, PhD at 1 site in United States.
Trial summary
In a true experiment, roughly 300 volunteer participants will smoke active cannabis, a corresponding placebo, or no substance at all (control). Next, participants will complete a drive test and then be observed by actual California Highway Patrol (CHP) officers who will attempt to classify participants as impaired or… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Smoking, Driving Impaired
- What is being tested?
- Active smoked cannabis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 31 Dec 2024
- Phase
- Phase 2
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Possessing a valid California driver's license
- Cannabis use in the past six months
- Willing and able to abstain from alcohol, cannabis, and other recreational drugs for 24 hours prior to scheduled participation
- Willing and able to avoid driving and operating heavy machinery for at least four hours after participation
- Residence within approximately 15 miles of the study site
- Possessing the capacity to provide informed consent
Who cannot join
- Completion of a roadside sobriety test during the previous 12 months
- Physical or psychological conditions that can be exacerbated by cannabis use, or for which cannabis use is contraindicated
- Potential presence of Cannabis Use Disorder as assessed by a modified version of the Cannabis Use Disorder Identification Test
- Potential presence of Substance Use Disorder as assessed by a modified version of the Drug Abuse Screening Test
- Pregnancy or breastfeeding reported
- Unwillingness to be transported by taxi
Show all 10Show fewer
- Having been convicted of Driving Under the Influence (DUI) within five years prior to scheduled participation
- Parole or probation status
- One or more felony convictions on record involving aggressive or dangerous criminal activity
- Any of the following at the time of the experimental session: breath alcohol content of .01% or greater; positive pregnancy test; cannabis consumption considered unsafe following medical checkup by the study nurse; or driving test behavior considered hazardous by the driving examiner
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
California Department of Motor Vehicles Headquarters
Sacramento, California, 95818-2606
Bayliss J Camp, PhD, 916-818-5312, alicepitt7@gmail.com
About this study
In a true experiment, roughly 300 volunteer participants will smoke active cannabis, a corresponding placebo, or no substance at all (control). Next, participants will complete a drive test and then be observed by actual California Highway Patrol (CHP) officers who will attempt to classify participants as impaired or unimpaired. CHP Officers will evaluate participants in the context of driving (i.e., while following participants in an actual patrol car), as part of a roadside behavioral assessment (i.e., the Advanced Roadside Impaired Driving Enforcement, or ARIDE, battery, which includes Standardized Field Sobriety Tests, or SFSTs), and as part of a Drug Recognition Expert (DRE) evaluation conducted indoors.
Read the detailed description
The easing of restrictions on the use of cannabis for recreational purposes presents a new challenge for policing of impaired driving, which is to say Driving Under the Influence of Drugs (DUI-D), specifically cannabis. In particular, it is not entirely clear how well the tools used by law enforcement officers to detect driving impairment (e.g., behavioral instruments such as the SFSTs, as included in the ARIDE battery) work for identifying cannabis-induced driving impairment specifically. While these instruments are designed to help officers identify driving impairment in general (irrespective of cause), prior empirical validation work has almost exclusively involved alcohol-induced impairment. This study will be conducted within a realistic, closed-course driving environment and it seeks to validate the same instruments currently used by law enforcement to detect cannabis-induced driving impairment against a second, independent, behavioral standard for driving impairment: a comprehensive driver evaluation adapted from the same set of driver tests that Californians must pass upon application for an original license, or (in certain instances) when referred to the Department of Motor Vehicles (DMV) for evaluation of their ability to safely operate a non-commercial class of motor vehicle (here referred to as the Modified Driver Performance Evaluation or MDPE).
This study seeks to answer the following research questions:
- How accurately do behavioral assessments used by officers distinguish between drivers impaired by cannabis and drivers not impaired by cannabis?
II. How does cannabis affect real-world (as opposed to simulated) driving performance?
- Conditions
- Cannabis Smoking, Driving Impaired
- Being tested
- Active smoked cannabis, Placebo smoked cannabis
- Medical subject headings
- Marijuana Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active smoked cannabisDrug
Also called marijuana, cannabis sativa, C. sativa L., C. sativa. Cannabis sativa L., Cannabis indica, C. indica
Assessment of active cannabis smoking and driving impairment
Placebo smoked cannabisDrug
Also called marijuana placebo, cannabis placebo, placebo marijuana, placebo cannabis
Assessment of placebo cannabis smoking and driving impairment
| Study group | Role | What they receive |
|---|---|---|
| Active Smoked Cannabis | Experimental | Participants in this arm will smoke an active cannabis cigarette containing 18.16% Δ9-tetrahydrocannabinol (THC). The smoking will occur at each participant's preferred pace, but will be limited to a maximum ten-minute period. While individual doses vary in this type of paradigm (ad libitum dosing), the anticipated dose of THC within the cannabis condition can be approximated by the following formula: (700 mg of cannabis) x [% of cigarette smoked; maximum of 70% (allowing room to hold the cigarette)] x (% THC). Therefore, the maximum dose in this arm is 700 mg x 70% x 18.2% = 89.18 mg of THC. Individual participants will only take part in the study under a single condition and receive the active cannabis once.
Bulk cannabis for this arm will be provided by the National Institute on Drug Abuse Drug Supply Program; cannabis cigarettes will be prepared and prescribed by the Research Pharmacy of the University of California, San Diego. Receives: Drug: Active smoked cannabis |
| Placebo Smoked Cannabis | Placebo comparator | Participants in this arm will smoke a placebo cannabis cigarette containing <.01 THC. The smoking will occur at each participant's preferred pace, but will be limited to a maximum ten-minute period. Individual participants will only take part in the study under a single condition and receive the placebo cannabis once.
Bulk placebo for this arm will be provided by the National Institute on Drug Abuse Drug Supply Program; placebo cannabis cigarettes will be prepared and prescribed by the Research Pharmacy of the University of California, San Diego. Receives: Drug: Placebo smoked cannabis |
| Control | No intervention | Participants in this arm receive no cannabis. Individual participants will only take part in the study under a single condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Driving Performance Examination (MDPE)
The MDPE driving test, developed for this study, is administered once per participant per experimental session. It occurs after the assigned intervention (i.e., drug administration) and it is primarily scored dichotomously (pass versus fail).
Measured: Conducted an average of 35 minutes after the assigned intervention is completed.
Advanced Roadside Impaired Driving Enforcement (ARIDE) battery
The ARIDE battery is not a scale but a series of roadside behavioral assessments used by law enforcement officers to help them detect impaired driving: (1) pulse check, (2) Horizontal Gaze Nystagmus or HGN, (3) a test of distinct and sustained nystagmus, (4) vertical nystagmus, (5) lack of convergence test, (6) a check to see if eyes are bloodshot or watery, (7) Modified Romberg Balance Test, (8) Walk and Turn Test or WAT, (9) One Leg Stand Test or OLS, and some additional observations.
The ARIDE battery occurs once per participant following the Modified Driving Performance Examination.
The ARIDE battery is scored overall as pass versus fail by the officer conducting the test (in real-time).
Measured: Conducted an average of 65 minutes after the assigned intervention is completed.
Drug Recognition Expert (DRE) evaluation
The DRE evaluation is designed to help law enforcement officers identify whether an individual is generally impaired and, if so, which class of substance caused the impairment.
The DRE evaluation occurs once per participant, following the ARIDE battery. It is scored by the officer conducting it in real-time as a judgment about state of impairment (impaired versus unimpaired), and, in the case of impairment, a judgment about the class of substance.
Measured: Conducted an average of 90 minutes after the assigned intervention is completed.
Secondary outcomes (3)
First blood draw (baseline)
The first blood sample is collected at baseline (after consent procedures and a medical checkup), roughly 25 minutes into the experimental session. This is before the assigned intervention (i.e., drug administration) and before any of the primary outcome measures occurs.
All samples will undergo toxicological analyses to assess blood concentrations (in nanograms per milliliter) of cannabinoids, as well as the presence of other drugs (opioids, benzodiazepines, and stimulants).
Measured: Conducted 15 minutes before the assigned intervention.
Second blood draw (change from baseline)
The second blood sample is collected immediately after the assigned intervention (i.e., drug administration), around the time that THC concentration is expected to be at its peak.
Most samples will undergo toxicological analyses to assess blood concentrations (in nanograms per milliliter) of cannabinoids and these results will be compared to those of the first blood draw. In the case of control participants whose first sample did not reveal the presence of cannabinoids, no further analyses will be conducted.
Measured: Conducted immediately after the assigned intervention is completed.
Third blood draw (change from baseline and second blood draw)
The third blood sample is collected after the Advanced Roadside Impaired Driving Enforcement (ARIDE) battery and immediately before the Drug Recognition Expert (DRE) evaluation.
Most samples will undergo toxicological analyses to assess blood concentrations (in nanograms per milliliter) of cannabinoids and these results will be compared to those of the first and second blood draws. In the case of control participants whose first sample did not reveal the presence of cannabinoids, no further analyses will be conducted.
Measured: Conducted an average of 85 minutes after the assigned intervention is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start3 Oct 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis SmokingStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a true experiment in a naturalistic setting designed to maximize ecological validity, that is, designed so that the findings can be expected to generalize to their real-world application of detecting impaired driving. The study features a randomized between-subjects design, in which the main independent variable (Substance) has three levels: active cannabis vs. placebo vs. control (i.e., no substance).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayliss J. Camp, PhD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Bayliss J. Camp, PhD, California Department of Motor Vehicles
- Investigators
- Bayliss J Camp, PhD, Principal investigator, California Department of Motor Vehicles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059677
- Sponsor's protocol ID
- 19C066000
- Status last verified
- Sep 2023
- First submitted
- 28 May 2021
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Consumption and Driving Impairment Assessment on a Closed Course
- ClinicalTrials.gov ID
- NCT06059677
- Acronym / sponsor ID
- 19C066000
- Conditions
- Cannabis Smoking, Driving Impaired
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bayliss J. Camp, PhDOther government
- Study start
- 3 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Sep 2023 (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.
In a true experiment, roughly 300 volunteer participants will smoke active cannabis, a corresponding placebo, or no substance at all (control). Next, participants will complete a drive test and then be observed by actual California Highway Patrol (CHP) officers who will attempt to classify participants as impaired or unimpaired. CHP Officers will evaluate participants in the context of driving (i.e., while following participants in an actual patrol car), as part of a roadside behavioral assessment (i.e., the Advanced Roadside Impaired Driving Enforcement, or ARIDE, battery, which includes Standardized Field Sobriety Tests, or SFSTs), and as part of a Drug Recognition Expert (DRE) evaluation conducted indoors.
Detailed description
The easing of restrictions on the use of cannabis for recreational purposes presents a new challenge for policing of impaired driving, which is to say Driving Under the Influence of Drugs (DUI-D), specifically cannabis. In particular, it is not entirely clear how well the tools used by law enforcement officers to detect driving impairment (e.g., behavioral instruments such as the SFSTs, as included in the ARIDE battery) work for identifying cannabis-induced driving impairment specifically. While these instruments are designed to help officers identify driving impairment in general (irrespective of cause), prior empirical validation work has almost exclusively involved alcohol-induced impairment. This study will be conducted within a realistic, closed-course driving environment and it seeks to validate the same instruments currently used by law enforcement to detect cannabis-induced driving impairment against a second, independent, behavioral standard for driving impairment: a comprehensive driver evaluation adapted from the same set of driver tests that Californians must pass upon application for an original license, or (in certain instances) when referred to the Department of Motor Vehicles (DMV) for evaluation of their ability to safely operate a non-commercial class of motor vehicle (here referred to as the Modified Driver Performance Evaluation or MDPE).
This study seeks to answer the following research questions:
- How accurately do behavioral assessments used by officers distinguish between drivers impaired by cannabis and drivers not impaired by cannabis?
II. How does cannabis affect real-world (as opposed to simulated) driving performance?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a true experiment in a naturalistic setting designed to maximize ecological validity, that is, designed so that the findings can be expected to generalize to their real-world application of detecting impaired driving. The study features a randomized between-subjects design, in which the main independent variable (Substance) has three levels: active cannabis vs. placebo vs. control (i.e., no substance).
| Arm | Type | Receives |
|---|---|---|
| Active Smoked Cannabis | Experimental | Drug: Active smoked cannabisParticipants in this arm will smoke an active cannabis cigarette containing 18.16% Δ9-tetrahydrocannabinol (THC). The smoking will occur at each participant's preferred pace, but will be limited to a maximum ten-minute period. While individual doses vary in this type of paradigm (ad libitum dosing), the anticipated dose of THC within the cannabis condition can be approximated by the following formula: (700 mg of cannabis) x [% of cigarette smoked; maximum of 70% (allowing room to hold the cigarette)] x (% THC). Therefore, the maximum dose in this arm is 700 mg x 70% x 18.2% = 89.18 mg of THC. Individual participants will only take part in the study under a single condition and receive the active cannabis once. Bulk cannabis for this arm will be provided by the National Institute on Drug Abuse Drug Supply Program; cannabis cigarettes will be prepared and prescribed by the Research Pharmacy of the University of California, San Diego. |
| Placebo Smoked Cannabis | Placebo comparator | Drug: Placebo smoked cannabisParticipants in this arm will smoke a placebo cannabis cigarette containing <.01 THC. The smoking will occur at each participant's preferred pace, but will be limited to a maximum ten-minute period. Individual participants will only take part in the study under a single condition and receive the placebo cannabis once. Bulk placebo for this arm will be provided by the National Institute on Drug Abuse Drug Supply Program; placebo cannabis cigarettes will be prepared and prescribed by the Research Pharmacy of the University of California, San Diego. |
| Control | No intervention | –Participants in this arm receive no cannabis. Individual participants will only take part in the study under a single condition. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Possessing a valid California driver's license
- Cannabis use in the past six months
- Willing and able to abstain from alcohol, cannabis, and other recreational drugs for 24 hours prior to scheduled participation
- Willing and able to avoid driving and operating heavy machinery for at least four hours after participation
- Residence within approximately 15 miles of the study site
Key exclusion criteria (10 listed)
- Completion of a roadside sobriety test during the previous 12 months
- Physical or psychological conditions that can be exacerbated by cannabis use, or for which cannabis use is contraindicated
- Potential presence of Cannabis Use Disorder as assessed by a modified version of the Cannabis Use Disorder Identification Test
- Potential presence of Substance Use Disorder as assessed by a modified version of the Drug Abuse Screening Test
- Pregnancy or breastfeeding reported
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 |
|---|---|---|
| Active smoked cannabisAlso: marijuana, cannabis sativa, C. sativa L., C. sativa. Cannabis sativa L., Cannabis indica, C. indicaAssessment of active cannabis smoking and driving impairment | Drug | Active Smoked Cannabis |
| Placebo smoked cannabisAlso: marijuana placebo, cannabis placebo, placebo marijuana, placebo cannabisAssessment of placebo cannabis smoking and driving impairment | Drug | Placebo Smoked Cannabis |
Primary outcome
Modified Driving Performance Examination (MDPE)
Time frame: Conducted an average of 35 minutes after the assigned intervention is completed.
The MDPE driving test, developed for this study, is administered once per participant per experimental session. It occurs after the assigned intervention (i.e., drug administration) and it is primarily scored dichotomously (pass versus fail).
Advanced Roadside Impaired Driving Enforcement (ARIDE) battery
Time frame: Conducted an average of 65 minutes after the assigned intervention is completed.
The ARIDE battery is not a scale but a series of roadside behavioral assessments used by law enforcement officers to help them detect impaired driving: (1) pulse check, (2) Horizontal Gaze Nystagmus or HGN, (3) a test of distinct and sustained nystagmus, (4) vertical nystagmus, (5) lack of convergence test, (6) a check to see if eyes are bloodshot or watery, (7) Modified Romberg Balance Test, (8) Walk and Turn Test or WAT, (9) One Leg Stand Test or OLS, and some additional observations. The ARIDE battery occurs once per participant following the Modified Driving Performance Examination. The ARIDE battery is scored overall as pass versus fail by the officer conducting the test (in real-time).
Drug Recognition Expert (DRE) evaluation
Time frame: Conducted an average of 90 minutes after the assigned intervention is completed.
The DRE evaluation is designed to help law enforcement officers identify whether an individual is generally impaired and, if so, which class of substance caused the impairment. The DRE evaluation occurs once per participant, following the ARIDE battery. It is scored by the officer conducting it in real-time as a judgment about state of impairment (impaired versus unimpaired), and, in the case of impairment, a judgment about the class of substance.
3 secondary outcomes
First blood draw (baseline)
Time frame: Conducted 15 minutes before the assigned intervention.
Second blood draw (change from baseline)
Time frame: Conducted immediately after the assigned intervention is completed.
Third blood draw (change from baseline and second blood draw)
Time frame: Conducted an average of 85 minutes after the assigned intervention is completed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- 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.
Bayliss J Camp, PhD principal investigator
California Department of Motor Vehicles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active smoked cannabis in people with Cannabis Smoking and Driving Impaired, run by Bayliss J. Camp, PhD 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 6 inclusion and 10 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 29 Sep 2023. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Dario LM Sacchi, PhD ((916) 818 5312, dario.sacchi2@dmv.ca.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Driving Performance Examination (MDPE) (time frame: Conducted an average of 35 minutes after the assigned intervention is completed.). 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?
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 29 Sep 2023.