Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-70
SponsorUniversity of California, San Diego
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Exclusion criteria will be: any substance use disorder (abuse or dependence) other than cannabis in the last 30 days;
Significant cognitive impairment such as Dementia, including Alzheimer's disease
Pregnancy or lactation, or unwillingness to prevent pregnancy during the trial; refusal to maintain highly effective contraceptive methods (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner) during the study for persons of child-bearing potential or those with partners of child-bearing potential
Evidence of moderately or worse compromised liver or kidney function, including moderate (Child-Hugh B) or severe (Child-Hugh C) hepatic impairment and AST and ALT above ULN and total bilirubin above ULN;
Trial design
Treatments tested in this trial
- THC
- CBD
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov