Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT05514899
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cannabis
  • HIV
  • Microbiome
  • Neuroinflammatory Disease
  • Neuroinflammatory Response
  • THC

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • THC — DRUG
    THC capsule
  • CBD — DRUG
    oral solution

Study Details

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.

Key Dates

Start date
Sep 1, 2023
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

PC1 [ Time Frame: Change from baseline to Week 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
HIV Neurobehavioral Research Program (HNRP)San DiegoCalifornia92103
Roberto Gallardo
[email protected]
619-543-5000
Ronald J Ellis, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By condition
HIV
By specialty
Infectious disease
By research site
HIV Neurobehavioral Research Program (HNRP)· San Diego, CA

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