Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Aug 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how two compounds found in cannabis, cannabidiol (CBD) and tetrahydrocannabinol (THC), affect the brain and inflammation in people living with HIV. The goal is to better understand how cannabis use and HIV interact, which could help develop new treatments for brain-related issues and inflammation. Participants will be randomly placed in one of two groups to receive the same treatment in a different order over about six weeks, including regular check-ups and tests to ensure their safety and to measure the effects of the treatment.

To be eligible for the trial, participants must be between 21 and 70 years old, have used cannabis at least once in the last five years without serious side effects, and be living with HIV under specific health conditions. They should also be willing to avoid using cannabis or similar substances during the study period. Participants can expect a series of visits that involve physical exams, blood tests, and other procedures to monitor their health. It's important to note that certain health conditions could exclude someone from participating, so it's best to discuss any concerns with a healthcare provider.

Gender

ALL

Eligibility criteria

• • 1. Aged 21 to 70 years old
• • 2. Possess the capacity to provide informed consent to a set of neuromedical assessment procedures.
• • 3. Experience with cannabis use at least once in the past 5 years without major adverse effects (e.g., psychosis, syncope)
• • 4. 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.
• • 5. Willing to abstain from use of cannabis, CBD, THC, or synthetic cannabinoids outside the study during the 6-week intervention
• • 6. Individuals with HIV must meet the following criteria
• • 1. Virally suppressed on stable ART for at least 6 months and have no more than 1 prior event of virologic failure (i.e., required change in ARTs due to virologic failure)
• • 2. Stage 1 or 2 infection
• • 3. Have a "normal" CD4 count defined as ≥350 cells/microliter
• • 4. No significant history of ART regimen adherence challenges
• • 7. Ability to adhere to the study visit schedule.
• Exclusion Criteria:
• • 1. Exclusion criteria will be: any substance use disorder (abuse or dependence) other than cannabis in the last 30 days;
• • 2. Significant cognitive impairment such as Dementia, including Alzheimer's disease
• • 3. 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
• • 4. 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;
• • 5. 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);
• • 6. Evidence of chronic pulmonary disease requiring supplemental oxygen;
• • 7. 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;
• • 8. Insulin dependent diabetics
• • 9. Allergy to the study drugs or any of their constituents including sesame
• • 10. Use of medications with absolute contraindicated or potential significant interactions
• • 11. Use of sedating medications
• • 12. Weighing less than 60 kg at screening to minimize the risk of elevated transaminases as a result of exposure to cannabidiol;
• • 13. 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).
• • 14. 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.