Cannabis Use, Cognition, and the Endocannabinoid System in HIV - Medical Cannabis Research Engine

INTERVENTIONALRECRUITINGNCT04883255

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 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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-05-01

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: EARLY PHASE1
Enrollment: 138 (ESTIMATED)
Start date: 2023-05-03
Sponsor: University of California, San Diego
Design: RANDOMIZED · PARALLEL · BASIC SCIENCE
Locations: 1
Results record: Not present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

cannabidiol Delta(9)-tetrahydrocannabinol

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

10 mg Δ9-tetrahydrocannabinol (THC)

5-day course of orally-administered THC (dronabinol), 10 mg

DRUG

600 mg cannabidiol (CBD)

5-day course of orally-administered CBD, 600 mg

DRUG

Placebo

5-day course of orally-administered placebo

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers

primary outcomes

primary measures

change in Iowa Gambling Task score from baseline to post-intervention

Time frame: baseline and 5 days after drug initiation

This is an experimental measure and not a scale with specific anchor points. Lower scores reflect increased risk-taking

change in Human Temporal Bisection Task score from baseline to post-intervention

Time frame: baseline and 5 days after drug initiation

This is an experimental measure and not a scale with specific anchor points. Scores reflect fast or slow perception of timing.

change in Probabilistic Learning Task score from baseline to post-intervention

Time frame: baseline and 5 days after drug initiation

This is an experimental measure and not a scale with specific anchor points. Lower scores reflect poorer learning.

change in Progressive Ratio Task score from baseline to post-intervention

Time frame: baseline and 5 days after drug initiation

This is an experimental measure and not a scale with specific anchor points. Lower scores reflect lower motivation or willingness to work for a reward.

change in Continuous Performance Task score from baseline to post-intervention

Time frame: baseline and 5 days after drug initiation

This is an experimental measure and not a scale with specific anchor points. Lower scores reflect worse attention.

change in human Behavioral Pattern Monitor activity and exploration score from baseline to post-intervention

Time frame: baseline and 5 days after drug initiation

This is an experimental measure and not a scale with specific anchor points. Higher scores reflect motor hyperactivity and increased exploration.

change in prepulse inhibition percentage score from baseline to post-intervention

Time frame: baseline and 5 days after drug initiation

This is an experimental measure and not a scale with specific anchor points. Lower scores reflect worse sensorimotor gating.

change in cerebrospinal fluid (CSF) anandamide (AEA) quantity from baseline to post-intervention

Time frame: baseline and 5 days after drug initiation

This is an experimental measure and not a scale with specific anchor points. Lower AEA signifies less amounts of this endocannabinoid in the central nervous system.

change in cerebrospinal fluid (CSF) 2-Arachidonoylglycerol (2-AG) quantity from baseline to post-intervention

Time frame: baseline and 5 days after drug initiation

This is an experimental measure and not a scale with specific anchor points. Lower 2-AG signifies less amounts of this endocannabinoid in the central nervous system.

change in cerebrospinal fluid (CSF) homovanillic acid (HVA) quantity from baseline to post-intervention

Time frame: baseline and 5 days after drug initiation

This is an experimental measure and not a scale with specific anchor points. Lower HVA signifies less amounts of this dopamine metabolite in the central nervous system.