Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04800159
Status:
RECRUITING
Last Update Posted:
2023-10-04
First Post:
2021-02-19
Brief Title:
Cannabis Effects on Antiretroviral Therapy Pharmacokinetics and Neurotoxicity
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Cannabis Effects on Antiretroviral Therapy Pharmacokinetics and Neurotoxicity
Status:
RECRUITING
Status Verified Date:
2023-10
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:
This study will address whether cannabis affects antiretroviral therapy ART drug concentrations mood and thinking The project will have two phases Phase 1 is an observational study in which 120 people will be assessed to evaluate the effects of chronic cannabis use on ART drug concentrations mood and thinking In Phase 2 the study will administer cannabis or placebo to 40 people to examine its acute effects on ART drug concentrations
Detailed Description:
People with human immunodeficiency virus HIV commonly use cannabis but whether cannabis affects the antiretroviral therapy ART that treats HIV is not well known Cannabis can inhibit the activity of enzymes that metabolize and eliminate ART drugs from the body which could result in higher concentrations of ART drugs in the body Cannabis may also affect the distribution of ART drugs into the brain which could have both beneficial eg better HIV control and detrimental eg toxicity effects The effects of cannabis may are likely influenced by factors like how much is used eg light vs heavy use and the route of use eg smoked vs ingested This study will address whether cannabis affects ART concentrations in blood and cerebrospinal fluid as well as mood and thinking The project will have two phases Phase 1 is an observational study in which 120 people will be assessed once to evaluate the effects of chronic cannabis use on ART drug concentrations mood and thinking In Phase 2 the study will administer cannabis or placebo to 40 people to examine its acute effects on ART drug concentrations
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None