Actively Recruiting
Effects of Cannabidiol and Tetrahydrocannabinol on the Microbiome, Endocannabinoids, and Neuroinflammation in HIV
Led by University of California, San Diego · Updated on 2026-05-01
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand how cannabis use and HIV independently and together affect the brain and inflammation. It focuses on people with HIV (PWH) and those without HIV (PWoH) to explore how gut bacteria and the body's endocannabinoid system relate to neuroinflammation and blood-brain barrier function. The study seeks to uncover how cannabis compounds may influence inflammation and gut health in these groups to inform future treatment strategies. Participants will take part in a randomized, cross-over clinical trial where 50 PWH and 50 PWoH receive oral doses of THC and CBD in different orders over about 6 weeks. One group takes 10 mg THC daily for 2 weeks, followed by a 2-week washout, then 600 mg CBD daily for 2 weeks. The other group receives the treatments in the reverse order. This design allows comparison of the effects of each cannabinoid on the microbiome, inflammation, and related systems. Throughout the study, participants will undergo physical exams, blood tests, and other procedures to monitor safety and measure treatment effects. Researchers will analyze changes in gut microbiota and blood-brain barrier function at set time points. Participants must adhere to visit schedules and abstain from cannabis use outside the study during the intervention. The study duration covers the 6-week treatment and washout periods, with assessments at baseline, week 2, week 4, and week 6.
CONDITIONS
Brief Title
Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 21 to 70 years old
- Ability to provide informed consent for neuromedical assessments
- Cannabis use at least once in the past 5 years without major adverse effects
- No or low cannabis use in the past 2 weeks (no use or only once)
- Willingness to abstain from cannabis, CBD, THC, or synthetic cannabinoids outside the study during the 6-week intervention
- For people with HIV: virally suppressed on stable antiretroviral therapy for at least 6 months with no more than one prior virologic failure event
- For people with HIV: stage 1 or 2 infection
- For people with HIV: normal CD4 count (≥350 cells/microliter)
- For people with HIV: no significant history of antiretroviral therapy adherence challenges
- Ability to follow the study visit schedule
You will not qualify if you...
- Substance use disorder other than cannabis within the last 30 days
- Significant cognitive impairment, including dementia or Alzheimer's disease
- Pregnancy, lactation, or unwillingness to use effective contraception during the study
- Moderately or severely compromised liver or kidney function
- Significant cardiovascular risk, including abnormal heart rate or blood pressure, history of heart disease
- Chronic pulmonary disease requiring supplemental oxygen
- History of hepatobiliary illness with elevated liver enzymes and bilirubin
- Insulin-dependent diabetes
- Allergy to study drugs or ingredients including sesame
- Use of medications with contraindications or significant interactions
- Use of sedating medications
- Weight under 60 kg at screening
- Active or uncontrolled psychiatric disorders with psychotic features, severe depression, or suicidality
- Neurologic disorders affecting study interpretation, such as recent seizures, multiple sclerosis, Parkinson's disease, Alzheimer's disease, or recent stroke with neurological effects
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 weeks
Participants receive two separate 2-week periods of daily oral THC and CBD, with a 2-week washout period in between, to evaluate effects on microbiome and neuroinflammation.
Daily dosing for 2 weeks, followed by 2-week washout, then daily dosing for 2 weeks
Trial Site Locations
Total: 1 location
1
HIV Neurobehavioral Research Program (HNRP)
San Diego, California, United States, 92103
Actively Recruiting
Research Team
R
Roberto Gallardo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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