Cannabis Use, Cognition, and the Endocannabinoid System in HIV
- Conditions
- HIV-1-infection
- Interventions
- Registration Number
- NCT04883255
- Lead Sponsor
- University of California, San Diego
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 138
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HIV-positive subjects 600 mg cannabidiol (CBD) Adult human subjects seropositive for HIV-1 HIV-positive subjects Placebo Adult human subjects seropositive for HIV-1 Healthy Comparison Volunteers Placebo Adult human subjects without HIV HIV-positive subjects 10 mg Δ9-tetrahydrocannabinol (THC) Adult human subjects seropositive for HIV-1 Healthy Comparison Volunteers 600 mg cannabidiol (CBD) Adult human subjects without HIV Healthy Comparison Volunteers 10 mg Δ9-tetrahydrocannabinol (THC) Adult human subjects without HIV
- Primary Outcome Measures
Name Time Method change in Iowa Gambling Task score from baseline to post-intervention 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 Progressive Ratio Task score from baseline to post-intervention 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 cerebrospinal fluid (CSF) 2-Arachidonoylglycerol (2-AG) quantity from baseline to post-intervention 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 Probabilistic Learning Task score from baseline to post-intervention 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 Human Temporal Bisection Task score from baseline to post-intervention 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 Continuous Performance Task score from baseline to post-intervention 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 cerebrospinal fluid (CSF) homovanillic acid (HVA) quantity from baseline to post-intervention 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.
change in human Behavioral Pattern Monitor activity and exploration score from baseline to post-intervention 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UC San Diego Medical Center-Hillcrest
🇺🇸San Diego, California, United States