Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04883255 · ClinicalTrials.gov registry record · Early Phase 1
Cannabis Use, Cognition, and the Endocannabinoid System in HIV
A Early Phase 1 study of HIV-1-infection, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 138
- Enrollment target
- 1
- Study location
NCT04883255 is a Early Phase 1 study of HIV-1-infection that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 138 participants, below the 349-participant average among 71 other HIV-1-infection trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04883255, a Early Phase 1 study of HIV-1-infection, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 138 participants
- Enrollment target
- 1
- Study location
Study Summary
Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functioning and transmission risk. The high prevalence of cannabis use in PWH, medicinally and recreationally, may indicate disease severity, impart therapeutic benefits, or adverse consequences. In fact, cannabis is recommended to those with HIV to alleviate nausea, improve appetite, relieve pain, and lift mood. To-date, the consequences of cannabis use in PWH remain unclear as do potential interactions with HIV treatments. In healthy participants, heavy cannabis use is associated with cognitive deficits e.g., risky decision-making, response disinhibition and inattention, but pro-cognitive effects in PWH may exist at mild use levels due to its anti-inflammatory and anti-excitotoxic properties. Furthermore, little has been done to determine the effects of cannabis use on the endocannabinoid (EC) system in general or in PWH. This study will determine the effects of the two primary cannabis constituents (Δ9-tetrahydrocannabinol \[THC\], cannabidiol \[CBD\]) vs. placebo on risky decision-making, response inhibition, reward learning, temporal perception, and motivation, plus EC and homovanillic acid (HVA; a surrogate for dopamine activity) levels in HIV+ and HIV- subjects. Participants with infrequent cannabis use will undergo baseline cognitive testing and biomarker assays with antiretrovirals (ART) use quantified. They will be randomized to a 5-day course of either THC, CBD, or placebo and return for follow-up testing and re-assaying of ECs and HVA levels.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG 10 mg Δ9-tetrahydrocannabinol (THC)
- DRUG 600 mg cannabidiol (CBD)
Study Locations (1)
California
- UC San Diego Medical Center-Hillcrest - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2023-05-03 |
| Est. Completion | 2026-01-31 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04883255
The ClinicalTrials.gov registry entry for NCT04883255 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 349-participant average among 71 other HIV-1-infection trials with a reported enrollment target (60% lower). The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04883255 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04883255 about?
NCT04883255 is a clinical study titled "Cannabis Use, Cognition, and the Endocannabinoid System in HIV". Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functioning and transmission risk. The high prevalence of cannabis use in PWH, medicinally and recreational...
What is the current status of trial NCT04883255?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 138 participants. The study started on 2023-05-03. Estimated completion is 2026-01-31.
What conditions does trial NCT04883255 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT04883255?
The interventions under investigation include: Placebo (DRUG), 10 mg Δ9-tetrahydrocannabinol (THC) (DRUG), 600 mg cannabidiol (CBD) (DRUG).
Who is sponsoring clinical trial NCT04883255?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04883255 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV-1-infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Pharmacokinetics Distribution of Raltegravir by PET/MR
RECRUITING · Early Phase 1
-
Impact of HIV-1 and Aging on Mucosal Vaccine Responses
ACTIVE NOT RECRUITING · Early Phase 1
-
Improving Coronary Vascular Health in Women
RECRUITING · Phase 2
-
Study of GS-3242 in Participants With HIV-1; Substudy-05
RECRUITING · Phase 1
-
Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers
RECRUITING · NA
-
Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States
RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.