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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA051295 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-positive subjects | Experimental | Adult human subjects seropositive for HIV-1 |
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| Healthy Comparison Volunteers | Active Comparator | Adult human subjects without HIV |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 mg Δ9-tetrahydrocannabinol (THC) | Drug | 5-day course of orally-administered THC (dronabinol), 10 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| change 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 | 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Crossby Vargas | Contact | 619-543-5000 | hnrprecruitment@ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Arpi Minassian, Ph.D. | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Medical Center-Hillcrest | Recruiting | San Diego | California | 92103-8620 | United States |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| 600 mg cannabidiol (CBD) | Drug | 5-day course of orally-administered CBD, 600 mg |
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| Placebo | Drug | 5-day course of orally-administered placebo |
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| 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. | 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. | 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. | 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. | baseline and 5 days after drug initiation |