Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV

• Status: Not yet recruiting
• Trial end date: 2027-10-31
• Target enrollment: 0
• Participant gender: All

Summary

We are conducting this study as it 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 effect of the study drug.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Cannabidiol; Dronabinol

Criteria

Inclusion Criteria:

• Aged 21 and older

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

• Experience with THC-containing 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 6 months, defined as no cannabis exposure or use or use limited to only once per month in the past 6 months.

• Individuals with HIV must be virally suppressed on stable ART for at least 3 months.

• Ability to adhere to the study visit schedule.

Exclusion Criteria:

• any substance use disorder (abuse or dependence) other than cannabis in the last 30 days;

• Pregnancy or lactation, or unwillingness to prevent pregnancy during the trial;

• Evidence of moderately or worse compromised liver or kidney function;

• Evidence of significant cardiovascular risk, uncontrolled hypertension, or chronic pulmonary disease requiring supplemental oxygen;

• Insulin dependent diabetics

• Use of contraindicated medications (e.g., warfarin);

• Active, uncontrolled psychiatric disorder with psychotic features, severe depression, or suicidality;

• Neurologic disorder that could compromise interpretation of study findings.