Recruiting
Phase 2

Cannabidiol & Tetrahydrocannabinol

Sponsor:

UCLA

Code:

NCT05514899

Conditions

HIV

Cannabis

THC

Neuroinflammatory Disease

Neuroinflammatory Response

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Accepted

Interventions

THC

CBD

Study Details

Brief 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.

Conditions

HIV

Cannabis

THC

Neuroinflammatory Disease

Neuroinflammatory Response

Study ID

NCT05514899

Start date

Sep 1, 2023

Status verified date

Apr, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: THC first, then CBD

THC 10mg daily for 2 weeks, followed by washout for 2 weeks, followed by CBD 600mg daily for 2 weeks

active comparator: CBD first, then THC

CBD 600mg daily for 2 weeks, followed by washout for 2 weeks, followed by THC 10mg daily for 2 weeks

Interventions

THC

THC capsule

CBD

oral solution

Primary outcome measure

  • PC1 [ Time Frame: Change from baseline to Week 2 ]
  • PC1 [ Time Frame: Change from Week 4 to Week 6 ]

Central Contacts and Locations

Central contacts

Locations

HIV Neurobehavioral Research Program (HNRP)

Recruiting

San Diego, California, United States, 92103

Contacts

Principal Investigator:

Ronald J Ellis, MD, PhD

More Information

Sponsor

University of California, San Diego

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-05-01.