Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
Study NCT ID:
NCT05287256
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2022-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Pharmacokinetic and Pharmacodynamic Effects of Delta-8 and Delta-9 THC
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Comparative Pharmacokinetic and Pharmacodynamic Effects of Delta-8 and Delta-9 THC
Status:
COMPLETED
Status Verified Date:
2024-10
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:
The current study will investigate the subjective, physiological, and cognitive performance effects of inhaled and orally ingested Delta-8 tetrahydrocannabinol (THC) in comparison to both placebo and Delta-9 THC. The purpose of this study is to assess the effects of Delta-8 THC as compared to placebo and Delta-9 THC. Oral fluid, urine, blood, and hair specimens will be collected from participants.
Detailed Description:
The current study will investigate the subjective, physiological, and cognitive performance effects of inhaled and orally ingested Delta-8 THC in comparison to both placebo and Delta-9 THC. Delta-8 THC is an cannabinoid that has become widely available for retail sale in the US due to a loophole in the 2018 Farm Bill. Delta-8 THC is an isomer of Delta-9 THC, which is the compound responsible for most of the psychoactive effects associated with cannabis. Prior research, while limited, has indicated that Delta-8 THC is less potent but has comparable pharmacodynamic effects to Delta-9 THC, especially at higher doses. The purpose of this study is to assess the effects of Delta-8 THC as compared to placebo and Delta-9 THC. Oral fluid, urine, blood, and hair specimens will be collected from participants. The investigators will recruit healthy participants between the ages of 18 and 45 who have prior experience using THC but have not used in at least one month. Two sub-studies will be run, with 5 conditions in each study; sub-study 1 will examine the effects of vaporized Delta-8 THC and sub-study 2 will assess the effects of orally ingested Delta-8 THC. Participants can complete both sub-studies but it is not required. There will be a minimum of 5 outpatient drug administration sessions for each participant, with the option to complete 5 more if interested. The investigators will recruit and consent up to 70 participants in order to obtain 20 completers (up to 40 total individuals) for each sub-study.
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?: