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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 70
Healthy Volunteers: t
View:

• Aged 21 to 70 years old

• Possess the capacity to provide informed consent to a set of neuromedical assessment procedures.

• Experience with cannabis use at least once in the past 5 years without major adverse effects (e.g., psychosis, syncope)

• No or low cannabis use in the past 2 weeks, defined as no cannabis exposure or use or use limited to only once in the past 2 weeks.

• Willing to abstain from use of cannabis, CBD, THC, or synthetic cannabinoids outside the study during the 6-week intervention

• Individuals with HIV must meet the following criteria

‣ Virally suppressed on stable ART for at least 6 months and have no more than 1 prior event of virologic failure (i.e., required change in ARTs due to virologic failure)

⁃ Stage 1 or 2 infection

⁃ Have a normal CD4 count defined as ≥350 cells/microliter

⁃ No significant history of ART regimen adherence challenges

• Ability to adhere to the study visit schedule.

Locations
United States
California
HIV Neurobehavioral Research Program (HNRP)
RECRUITING
San Diego
Contact Information
Primary
Roberto Gallardo
hnrprecruitment@ucsd.edu
619-543-5000
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 90
Treatments
Experimental: THC first, then CBD
THC 10mg daily for 2 weeks, followed by washout for 2 weeks, followed by CBD 600mg daily for 2 weeks
Active_comparator: CBD first, then THC
CBD 600mg daily for 2 weeks, followed by washout for 2 weeks, followed by THC 10mg daily for 2 weeks
Related Therapeutic Areas
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov