NCT04883255 Cannabis Use, Cognition, and the Endocannabinoid System in HIV
| NCT ID | NCT04883255 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of California, San Diego |
| Condition | HIV-1-infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2023-05-03 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 138 participants in total. It began in 2023-05-03 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Arpi Minassian, Ph.D.
PRINCIPAL INVESTIGATOR
UC San Diego
Frequently Asked Questions
Who can join the NCT04883255 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying HIV-1-infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04883255 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04883255 currently recruiting?
Yes, NCT04883255 is actively recruiting participants. Contact the research team at hnrprecruitment@ucsd.edu for enrollment information.
Where is the NCT04883255 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT04883255 clinical trial?
NCT04883255 is sponsored by University of California, San Diego. The principal investigator is Arpi Minassian, Ph.D. at UC San Diego. The trial plans to enroll 138 participants.
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