CannabisPhase 1NCT03699540
Marijuana Effects on Simulated Driving Performance
A Phase 1 study testing Marijuana, Alcohol and Inactive marijuana in people with Cannabis and Cannabis Use, run by Shanna Babalonis, PhD at 1 site in United States.
Trial summary
This study will examine the effects of various strains of marijuana on simulated driving performance; the effects of alcohol administration will also be examined to further understand how marijuana-induced driving changes compare to the effects of alcohol. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis, Cannabis Use, Marijuana
- What is being tested?
- Marijuana, Alcohol and Inactive marijuana
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 1 Jan 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult participants
- Ages 21-50
- History of marijuana use
- History of alcohol use
Who cannot join
- Clinically significant medical conditions
- Ongoing/significant drug use outside of marijuana and alcohol use
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine the effects of various strains of marijuana on simulated driving performance; the effects of alcohol administration will also be examined to further understand how marijuana-induced driving changes compare to the effects of alcohol. Secondary outcomes will include physiological effects, subjective- and observer-rated outcomes, and psychomotor performance under the various dose conditions.
- Conditions
- Cannabis, Cannabis Use, Marijuana, Marijuana Usage, Alcohol Drinking
- Being tested
- Marijuana, Alcohol, placebo alcohol, Inactive marijuana
- Keywords
- simulated driving, outpatient
- Medical subject headings
- Marijuana Abuse, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarijuanaDrug
Also called Active cannabis
Experimental, non-therapeutic administration of active marijuana dose(s)
AlcoholDrug
Also called Active alcohol
Experimental, non-therapeutic administration of active alcohol dose(s)
placebo alcoholDrug
Experimental, non-therapeutic administration of inactive alcohol dose(s)
Inactive marijuanaDrug
Also called inactive cannabis
Experimental, non-therapeutic administration of inactive marijuana dose(s)
| Study group | Role | What they receive |
|---|---|---|
| Active Marijuana Dose | Experimental | Participants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions Receives: Drug: Marijuana |
| Inactive Marijuana Dose | Placebo comparator | Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions Receives: Drug: Inactive marijuana |
| Active Alcohol Dose | Active comparator | Participants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions Receives: Drug: Alcohol |
| Inactive Alcohol Dose | Placebo comparator | Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions Receives: Drug: placebo alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Peak for Standard Deviation in Lane Position (SDLP)
Standard deviation of lane position (SDLP) of the car is the amount of weaving/swerving of the car in and out of the lane. It is a frequent metric for assessing driving ability.
Measured: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
Secondary outcomes (5)
Subject-Rated Outcomes: Mean Peak Score for Driving Difficulty
Participants rated their subjective response on a standardized VAS scale (0 to 100). Higher scores indicate worse outcome/greater impairment. Raw data transformed to peak scores.
Measured: This outcome (VAS score) was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
Subject-Rated Outcome: Mean Peak Score for Drug and Alcohol Effect
Participants rated their subjective response on a standardized VAS scale (0 to 100). Higher scores indicate greater drug effects. Raw data transformed to peak scores.
Measured: This outcome (VAS scores) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs)
Subject-Rated Outcome: Mean Peak Score for Difficulty Concentrating
Participants rated their subjective response on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores.
Measured: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
Observer-Rated Outcome: Mean Peak Score for Relaxed
Research observer rated on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores.
Measured: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
Observer-Rated Outcome: Mean Peak Score for Good Mood
Research observer rated on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores.
Measured: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Jul 2019
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Sequential
- Model description
- Within-subject, randomized, placebo-controlled, double-dummy, double-blind study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanna Babalonis, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Shanna Babalonis, PhD, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699540
- Sponsor's protocol ID
- 43636
- Other IDs
- R21DA045101-02
- Status last verified
- Jul 2024
- First submitted
- 2 Oct 2018
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data with other outside researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marijuana Effects on Simulated Driving Performance
- ClinicalTrials.gov ID
- NCT03699540
- Acronym / sponsor ID
- 43636
- Conditions
- Cannabis, Cannabis Use, Marijuana, Marijuana Usage, Alcohol Drinking
- Keywords
- simulated driving, outpatient
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shanna Babalonis, PhDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the effects of various strains of marijuana on simulated driving performance; the effects of alcohol administration will also be examined to further understand how marijuana-induced driving changes compare to the effects of alcohol. Secondary outcomes will include physiological effects, subjective- and observer-rated outcomes, and psychomotor performance under the various dose conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Within-subject, randomized, placebo-controlled, double-dummy, double-blind study
| Arm | Type | Receives |
|---|---|---|
| Active Marijuana Dose | Experimental | Drug: MarijuanaParticipants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions |
| Inactive Marijuana Dose | Placebo comparator | Drug: Inactive marijuanaParticipants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions |
| Active Alcohol Dose | Active comparator | Drug: AlcoholParticipants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions |
| Inactive Alcohol Dose | Placebo comparator | Drug: placebo alcoholParticipants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy, adult participants
- Ages 21-50
- History of marijuana use
- History of alcohol use
Key exclusion criteria (2 listed)
- Clinically significant medical conditions
- Ongoing/significant drug use outside of marijuana and alcohol use
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 |
|---|---|---|
| MarijuanaAlso: Active cannabisExperimental, non-therapeutic administration of active marijuana dose(s) | Drug | Active Marijuana Dose |
| AlcoholAlso: Active alcoholExperimental, non-therapeutic administration of active alcohol dose(s) | Drug | Active Alcohol Dose |
| placebo alcoholExperimental, non-therapeutic administration of inactive alcohol dose(s) | Drug | Inactive Alcohol Dose |
| Inactive marijuanaAlso: inactive cannabisExperimental, non-therapeutic administration of inactive marijuana dose(s) | Drug | Inactive Marijuana Dose |
Primary outcome
Mean Peak for Standard Deviation in Lane Position (SDLP)
Time frame: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
Standard deviation of lane position (SDLP) of the car is the amount of weaving/swerving of the car in and out of the lane. It is a frequent metric for assessing driving ability.
5 secondary outcomes
Subject-Rated Outcomes: Mean Peak Score for Driving Difficulty
Time frame: This outcome (VAS score) was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
Subject-Rated Outcome: Mean Peak Score for Drug and Alcohol Effect
Time frame: This outcome (VAS scores) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs)
Subject-Rated Outcome: Mean Peak Score for Difficulty Concentrating
Time frame: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
Observer-Rated Outcome: Mean Peak Score for Relaxed
Time frame: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
Observer-Rated Outcome: Mean Peak Score for Good Mood
Time frame: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data with other outside researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Marijuana, Alcohol and Inactive marijuana in people with Cannabis and Cannabis Use, run by Shanna Babalonis, 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 31 Jul 2024. 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 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?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Peak for Standard Deviation in Lane Position (SDLP) (time frame: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.). 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 31 Jul 2024.