Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-28 @ 5:35 AM
Study NCT ID:
NCT06218550
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2024-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delta-8-THC vs. Delta-9-THC on Simulated Driving Performance
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
The Effect of Delta-8-THC vs Delta-9-THC on Simulated Driving Performance and Measures of Impairment
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
The present study will characterize the acute effects of oral and inhaled ∆8-THC, compared with a positive control dose of ∆9-THC and placebo, on subjective drug effects, cardiovascular effects, cognitive performance, simulated driving performance, field sobriety tests, and drug testing outcomes in oral fluid, blood, hair, and urine. Healthy adults with a history of cannabis use will be recruited to participate in a placebo-controlled, within-subject crossover study at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). The result will be a comparative pharmacology and toxicology dataset for ∆8-THC and ∆9-THC via both oral ingestion and inhalation, two routes of administration that are predominant in retail products currently being sold across the U.S. This study will provide urgently needed data on the behavioral pharmacology and toxicology of ∆8-THC, a novel cannabinoid that is now widely available, but for which there is little public knowledge or public health messaging. This data will directly inform the impact of ∆8-THC use on drug testing programs, and the comparative effects of ∆8-THC to ∆9-THC can be used to inform regulatory decisions related to public safety and the sale of these products.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: