Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT04883255

Cannabis Use, Cognition, and the Endocannabinoid System in HIV

Led by University of California, San Diego · Updated on 2026-05-01

138

Participants Needed

1

Research Sites

164 weeks

Total Duration

On this page

Sponsors

U

University of California, San Diego

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Cannabis Use, Cognition, and the Endocannabinoid System in HIV

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-65
  • Able to provide informed consent for neurobehavioral, neuromedical, and cognitive assessments
  • Willing to confirm self-reported HIV status with a rapid test
  • Willing to abstain from cannabis for at least one week before baseline visit and throughout the study, confirmed by oral fluid testing
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Significant chronic kidney or lung disease not related to HIV
  • Hepatitis C Virus infection
  • Head injury with loss of consciousness over 30 minutes or neurologic complications
  • Seizure disorders
  • Demyelinating or other non-HIV neurological disorders
  • Pregnancy
  • Recent or past disabling stroke or cerebrovascular events
  • History of schizophrenia, other psychotic disorders, or bipolar disorder
  • Severe depression or suicidal thoughts as measured by depression scales
  • Substance use disorder within the last 12 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UC San Diego Medical Center-Hillcrest

San Diego, California, United States, 92103-8620

Actively Recruiting

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Research Team

C

Crossby Vargas

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Cannabis Use, Cognition, and the Endocannabinoid System in HIV | DecenTrialz