Cannabis Use, Cognition, and the Endocannabinoid System in HIV

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT04883255
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • HIV-1-infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 10 mg Δ9-tetrahydrocannabinol (THC) — DRUG
    5-day course of orally-administered THC (dronabinol), 10 mg
  • 600 mg cannabidiol (CBD) — DRUG
    5-day course of orally-administered CBD, 600 mg
  • Placebo — DRUG
    5-day course of orally-administered placebo

Study Details

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.

Key Dates

Start date
May 3, 2023
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: HIV-positive subjects
    Adult human subjects seropositive for HIV-1
  • Active Comparator: Healthy Comparison Volunteers
    Adult human subjects without HIV

Primary Outcome Measure

change in Iowa Gambling Task score from baseline to post-intervention [ Time Frame: baseline and 5 days after drug initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC San Diego Medical Center-HillcrestSan DiegoCalifornia92103-8620
Arpi Minassian, PhD
[email protected]
6195433422
Roberto Gallardo
[email protected]

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By research site
UC San Diego Medical Center-Hillcrest· San Diego, CA

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