Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV

Recruiting now · Phase 2

Conditions studied: HIV, Cannabis, THC, Neuroinflammatory Disease, Neuroinflammatory Response, Microbiome

In brief

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 facts

Study ID

NCT05514899

Run by

University of California, San Diego

People needed

90

Starts

2023-09-01

Expected to finish

2027-10-31

Last updated by the study team

2026-05-01

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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;
• Evidence of significant cardiovascular risk, resting heart rate <50 or >110 beats per minute, uncontrolled hypertension (systolic blood pressure <80 or >140 mmHg; diastolic blood pressure <50 or >90 mmHg), history of myocardial infarction, congestive heart failure, or arrhythmia);
• Evidence of chronic pulmonary disease requiring supplemental oxygen;
• Active, recent, or remote medical history of hepatobiliary-related illness, including elevated transaminase levels above 3 times the upper limit of normal accompanied by elevations in total bilirubin above 2 times the upper limit of normal at screening;
• Insulin dependent diabetics
• Allergy to the study drugs or any of their constituents including sesame
• Use of medications with absolute contraindicated or potential significant interactions
• Use of sedating medications
• Weighing less than 60 kg at screening to minimize the risk of elevated transaminases as a result of exposure to cannabidiol;
• Active, uncontrolled psychiatric disorder with psychotic features, severe depression, or suicidality; Participants will be excluded if they have had a history of suicide attempt, recent suicidal ideation or behavior as indexed by their Beck Depression Inventory-II (BDI-II) score is greater than or equal to 29 (severe depression).
• Neurologic disorder that could compromise interpretation of study findings, including uncontrolled seizure disorder (active seizures within the past 3 months), multiple sclerosis, Parkinson's disease, Alzheimer's disease, and recent (past 3 months) cerebral infarction or hemorrhage with neurological sequelae.

Where it is running

• HIV Neurobehavioral Research Program (HNRP) — San Diego, California, United States (enrolling)

Full record on ClinicalTrials.gov

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