Effects of cannabis on cognition in people with HIV
Cannabis Use, Cognition, and the Endocannabinoid System in HIV
This study is testing how cannabis affects thinking and decision-making in people with HIV to see if it helps or harms their cognitive abilities.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT04883255 on ClinicalTrials.gov |
What this trial studies
This study investigates how cannabis use affects cognitive behaviors such as decision-making and risk-taking in individuals living with HIV. It aims to understand the potential therapeutic benefits or adverse consequences of cannabis, particularly focusing on the effects of THC and CBD on cognitive function. Participants will be administered either THC, CBD, or a placebo, and their cognitive performance will be assessed. The study also explores the interactions between cannabis use and HIV treatments, particularly in those who use cannabis infrequently.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with HIV who use cannabis infrequently and can provide informed consent.
Not a fit: Patients who use cannabis frequently or have severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how cannabis may be used to improve cognitive function and overall quality of life for individuals living with HIV.
How similar studies have performed: While there is limited research specifically on cannabis use in HIV patients, studies on cannabis and cognition in other populations suggest mixed results, indicating that this approach is novel and requires further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Aged 18-65 2. Possess the capacity to provide informed consent to a set of neurobehavioral, neuromedical and cognitive assessment procedures. Individuals unable to provide such consent will not be enrolled into the study. 3. Willing to confirm self-reported HIV using a rapid test: HIV status will be determined using the MedMira Rapid Test (Halifax, Nova Scotia, Canada). If the result differs from the participant's self-report a confirmatory Western Blot will be performed. 4. Willing to abstain from cannabis for at least 1 week prior to the baseline visit and during the study. Although there is no definitive method for determining abstinence over this period, abstinence will be confirmed as best as possible by using an oral fluid testing device (Draeger 5000) employed by law enforcement officers to detect recent cannabis use. An oral fluid value of \> 5ng suggests recent use, although in some cases it has been reported that individuals may show \> 5ng up to 20 hours after use. Thus, should the oral fluid sample indicate \> 5ng THC, the assessment may be canceled and rescheduled. Exclusion Criteria * Inability to provide informed consent * Significant chronic renal disease (unrelated to HIV), significant chronic pulmonary disease (unrelated to HIV), or Hepatitis C Virus infection * Head injury with loss of consciousness for greater than 30 minutes or resulting in neurologic complications * Seizure disorder * Demyelinating diseases or other non-HIV neurological disorders * Pregnancy * Acute or recent or previous clinically disabling stroke or previous cerebrovascular events * Lifetime history of schizophrenia or other psychotic disorders, or bipolar disorder. * Beck Depression Inventory-II (BDI-II) score is greater than or equal to 29 (severe depression) or suicidal ideas are endorsed on the BDI-II or a Center for Epidemiological Studies-Depression Scale (CES-D) subscale measuring suicidal ideation * Substance use disorder (mild, moderate or severe) within the last 12 months
Where this trial is running
San Diego, California
- UC San Diego Medical Center-Hillcrest — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Arpi Minassian, Ph.D. — UC San Diego
- Study coordinator: Crossby Vargas
- Email: hnrprecruitment@ucsd.edu
- Phone: 619-543-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.