Comparing the effects of Delta-8-THC and Delta-9-THC on driving performance

The Effect of Delta-8-THC vs Delta-9-THC on Simulated Driving Performance and Measures of Impairment

This study is testing how Delta-8-THC and Delta-9-THC affect driving skills and thinking in healthy adults who use cannabis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06218550 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of Delta-8-THC, an isomer of Delta-9-THC, on simulated driving performance and cognitive functions. Participants will be healthy adults with a history of cannabis use, who will undergo a placebo-controlled, within-subject crossover design. The study will compare the effects of both cannabinoids administered via oral ingestion and inhalation, assessing subjective drug effects, cardiovascular impacts, and drug testing outcomes. The findings aim to provide essential data for public health messaging and regulatory decisions regarding Delta-8-THC use.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 55 with a history of cannabis use and a valid driver's license.

Not a fit: Patients who do not use cannabis or have a history of non-medical use of psychoactive drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of the safety and impairment risks associated with Delta-8-THC, informing public health policies.

How similar studies have performed: While there is limited research specifically on Delta-8-THC, studies on Delta-9-THC have shown significant effects on driving performance, suggesting potential relevance for this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Be between the ages of 18 and 55
2. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
3. Test negative for recent cannabis use prior to each experimental test session
4. Test negative for drugs of abuse and alcohol prior to each experimental test session
5. 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
6. Have a body mass index (BMI) in the range of 19 to 36 kg/m2
7. 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
8. Have not donated blood in the prior 30 days.
9. Have a current government-issued driver's license

Exclusion Criteria:

1. Non-medical use of psychoactive drugs other than nicotine, alcohol, or caffeine in the month prior to study participation.
2. 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.
3. Current concomitant medication use that may interact with the study drug (∆8-THC and ∆9-THC).
4. 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.
5. Participation in other research projects that could impact the present study

Where this trial is running

Baltimore, Maryland

• Johns Hopkins Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Ryan Vandrey, PhD — Johns Hopkins University
• Study coordinator: Ryan Vandrey, PhD

Conditions Cannabis