RecruitingPhase 2NCT05514899

Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV

Effects of Cannabidiol and Tetrahydrocannabinol on the Microbiome, Endocannabinoids, and Neuroinflammation in HIV

Sponsor

University of California, San Diego

Enrollment

90 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Microbiome HIV Cannabis THC Neuroinflammatory Disease Neuroinflammatory Response

Summary

This study has the potential to contribute to a more complete understanding of the independent and combined effects of cannabis use and HIV on the brain and on inflammation. Such knowledge may inform future strategies for treating brain disease and inflammation. Participants will be randomly assigned to one of two groups, both of which will receive the same treatment in a different order over a period of about 6 weeks. The visits include physical examinations, blood tests, and other procedures designed to monitor subject safety and measure the effects of the study drug.

Eligibility

Min Age: 21 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study examines how cannabidiol (CBD) and THC (the active compounds in cannabis) affect the gut microbiome (intestinal bacteria) and brain inflammation in people living with HIV. Chronic HIV infection can cause low-level brain inflammation, and cannabis may help reduce this. The study is a randomized trial comparing CBD-dominant oil, THC-dominant oil, and a placebo. **You may be eligible if...** - You are between 21 and 70 years old - You are living with HIV, virally suppressed on stable antiretroviral therapy (ART) for at least 6 months - You have used cannabis at least once in the past 5 years without serious problems - You have used cannabis minimally or not at all in the past 2 weeks - You are willing to abstain from outside cannabis use during the 6-week study **You may NOT be eligible if...** - You have a history of psychosis or severe psychiatric illness - You are not virally suppressed on HIV treatment - You are pregnant or breastfeeding - You currently use cannabis heavily or regularly - You have serious liver, heart, or kidney conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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