Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV (NCT05514899) | Clinical Trial Compass
RecruitingPhase 2
Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV
United States90 participantsStarted 2023-09-01
Plain-language summary
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.
Who can participate
Age range21 Years – 70 Years
SexALL
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Exclusion criteria
✕. 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;