Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV

NCT05514899 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 802514
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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; Microbiome

Outcome Measures

Primary Outcomes (2)

• PC1

  A composite marker of inflammation, comprising the first component (PC1, a unitless measure) of the principal component analysis (PCA) of 7 soluble biomarkers in blood (soluble CD163 \[sCD163\], interferon gamma \[IFN-gamma\], interleukin 6 \[IL-6\], C-reactive protein \[CRP\], CC motif chemokine ligand 2 \[CCL2\], neopterin and soluble tumor necrosis factor - type II \[sTNFRII\]), all measured in picograms/milliliter

  Change from baseline to Week 2

• PC1

  A composite marker of inflammation, comprising the first component (PC1, a unitless measure) of the principal component analysis (PCA) of 7 soluble biomarkers in blood (soluble CD163 \[sCD163\], interferon gamma \[IFN-gamma\], interleukin 6 \[IL-6\], C-reactive protein \[CRP\], CC motif chemokine ligand 2 \[CCL2\], neopterin and soluble tumor necrosis factor - type II \[sTNFRII\]), measured in picograms/milliliter

  Change from Week 4 to Week 6

Secondary Outcomes (2)

• blood-brain barrier (BBB)

  Change from baseline to Week 2

• blood-brain barrier (BBB)

  Change from Week 4 to Week 6

Study Arms (2)

THC first, then CBD

EXPERIMENTAL

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

Drug: THC; Drug: CBD

CBD first, then THC

ACTIVE COMPARATOR

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

Drug: THC; Drug: CBD

Interventions

THC DRUG

THC capsule

Also known as: Delta-9 tetrahydrocannabinol, Tetrahydrocannabinol, Delta9-THC

CBD first, then THC; THC first, then CBD

CBD DRUG

oral solution

Also known as: Cannabidiol

CBD first, then THC; THC first, then CBD

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

HIV Neurobehavioral Research Program (HNRP)

San Diego, California, 92103, United States

RECRUITING

MeSH Terms

Conditions

Marijuana Abuse; Neuroinflammatory Diseases

Interventions

Dronabinol; Cannabidiol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Ronald J Ellis, MD, PhD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Gallardo

CONTACT

619-543-5000; hnrprecruitment@ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This will be a double-blind, randomized, 2-sequence crossover trial of CBD versus THC to reduce systemic and neuro-inflammation. This design was chosen to balance consideration of addressing the key scientific questions (effects of CBD versus THC on the microbiome, ECS and inflammation and their interaction with HIV infection), scientific rigor, power and feasibility.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 25, 2022
• Study Start: September 1, 2023
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)