Delta-8-THC vs. Delta-9-THC on Simulated Driving Performance (NCT06218550) | Clinical Trial Compass
CompletedPhase 1
Delta-8-THC vs. Delta-9-THC on Simulated Driving Performance
United States30 participantsStarted 2024-07-01
Plain-language summary
Delta-8-THC is an isomer of delta-9-THC that has become widely available due to the legalization of hemp and its derivatives. Very little controlled research has been conducted with delta-8-THC and some research suggests it produces similar effects to delta-9-THC, albeit at lower potency. The present study will evaluate the dose effects of delta-8-THC, compared with delta-9-THC, on simulated driving performance, field sobriety tests, cognitive performance, and biomarkers of exposure to cannabinoids. The results will inform policy and education related to impairment due to acute delta-8-THC exposure via vaporization and oral ingestion.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be between the ages of 18 and 55
. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
. Test negative for recent cannabis use prior to each experimental test session
. Test negative for drugs of abuse and alcohol prior to each experimental test session
. Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission
. Have a body mass index (BMI) in the range of 19 to 36 kg/m2
. Report use of cannabis in the past 3 years (both sub-studies) and prior experience inhaling cannabis (either via smoking or vaporization) for vaporization sub-study participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Standard Deviation of Lateral Position (SDLP) in cm
. Non-medical use of psychoactive drugs other than nicotine, alcohol, or caffeine in the month prior to study participation.
. History of or current evidence of health issues judged by the investigator to put the participant at greater risk of experiencing an adverse event due to drug exposure or completion of other study procedures.
. Current concomitant medication use that may interact with the study drug (∆8-THC and ∆9-THC).
. History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
. Participation in other research projects that could impact the present study