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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
138
5-day course of orally-administered THC (dronabinol), 10 mg
5-day course of orally-administered CBD, 600 mg
5-day course of orally-administered placebo
UC San Diego Medical Center-Hillcrest
San Diego, California, United States
RECRUITINGchange in Iowa Gambling Task score from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect increased risk-taking
Time frame: baseline and 5 days after drug initiation
change in Human Temporal Bisection Task score from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Scores reflect fast or slow perception of timing.
Time frame: baseline and 5 days after drug initiation
change in Probabilistic Learning Task score from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect poorer learning.
Time frame: baseline and 5 days after drug initiation
change in Progressive Ratio Task score from baseline to post-intervention
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.
Time frame: baseline and 5 days after drug initiation
change in Continuous Performance Task score from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect worse attention.
Time frame: baseline and 5 days after drug initiation
change in human Behavioral Pattern Monitor activity and exploration score from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Higher scores reflect motor hyperactivity and increased exploration.
Time frame: baseline and 5 days after drug initiation
change in prepulse inhibition percentage score from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect worse sensorimotor gating.
Time frame: baseline and 5 days after drug initiation
change in cerebrospinal fluid (CSF) anandamide (AEA) quantity from baseline to post-intervention
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.
Time frame: baseline and 5 days after drug initiation
change in cerebrospinal fluid (CSF) 2-Arachidonoylglycerol (2-AG) quantity from baseline to post-intervention
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.
Time frame: baseline and 5 days after drug initiation
change in cerebrospinal fluid (CSF) homovanillic acid (HVA) quantity from baseline to post-intervention
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.
Time frame: baseline and 5 days after drug initiation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.