Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID04883255

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

N/A

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

Researchers are studying how co-existing conditions like substance use affect decision-making and cognitive behaviors in people with HIV (PWH). The study focuses on the effects of cannabis, which is commonly used by PWH for symptoms like nausea, appetite loss, pain, and mood. The trial will explore how cannabis affects risky decision-making, response control, reward learning, time perception, motivation, and brain chemical levels in both HIV-positive and HIV-negative adults. Participants who use cannabis infrequently will first complete baseline cognitive tests and biomarker assessments, including measuring antiretroviral therapy use. They will then be randomly assigned to receive one of three treatments for five days: oral THC (10 mg), oral cannabidiol (CBD, 600 mg), or a placebo. Follow-up testing and biomarker reassessment will occur after the treatment period. During the study, participants will undergo various cognitive and behavioral tests such as the Iowa Gambling Task, Temporal Bisection Task, and Continuous Performance Task, among others. Biomarker levels in cerebrospinal fluid will also be measured before and after treatment. The main outcomes include changes in cognitive task scores and brain chemical quantities from baseline to five days after starting the study drug. The study is sponsored by the University of California, San Diego, and includes adults aged 18 to 65 years.

CONDITIONS

Brief 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 years
  • Able to provide informed consent for neurobehavioral and cognitive assessments
  • Willing to confirm HIV status using a rapid test
  • Willing to abstain from cannabis for at least one week before and during 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 unrelated to HIV
  • Hepatitis C virus infection
  • Head injury with loss of consciousness over 30 minutes or neurological complications
  • Seizure disorders
  • Non-HIV neurological diseases such as demyelinating disorders
  • Pregnancy
  • Recent or past disabling stroke or cerebrovascular events
  • History of schizophrenia, psychotic disorders, or bipolar disorder
  • Severe depression or suicidal thoughts as measured by standardized 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 days

Participants receive a 5-day course of orally-administered drug (THC, CBD, or placebo) to study effects on cognition and the endocannabinoid system.

1 baseline visit and 1 follow-up visit within 5 days after drug initiation

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

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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