Cannabis Derivatives for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does require participants to abstain from cannabis for at least 2 days before the baseline visit.
Is CBD safe for human use?
How is the drug Cannabidiol and Δ9-tetrahydrocannabinol unique for treating HIV?
This drug is unique because it combines Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) to potentially reduce inflammation in people with HIV, which is not typically addressed by standard antiretroviral therapy. CBD, in particular, has shown anti-inflammatory properties without the psychoactive effects of THC, making it a novel option for managing chronic inflammation associated with HIV.26789
What evidence supports the effectiveness of the drug for reducing inflammation in people with HIV?
Research shows that cannabinoids like CBD and THC can reduce inflammation in people with HIV, which is important because chronic inflammation can lead to other health problems. Studies have found that these compounds can decrease inflammatory markers and improve immune cell function, suggesting potential benefits as an additional treatment alongside standard HIV therapy.126710
Who Is on the Research Team?
Arpi Minassian, Ph.D.
Principal Investigator
UC San Diego
Are You a Good Fit for This Trial?
This trial is for adults over 18 with HIV who can consent to tests and have used cannabis infrequently (1-4 times per month) without adverse reactions. They must be willing to avoid cannabis for at least 2 days before the study starts, confirmed by an oral fluid test.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline cognitive testing and biomarker assays with antiretrovirals (ART) use quantified
Treatment
Participants are randomized to a 5-day course of either THC, CBD, or placebo
Follow-up
Participants return for follow-up testing and re-assaying of ECs and HVA levels
What Are the Treatments Tested in This Trial?
Interventions
- Cannabidiol
- Placebo
- Δ9-tetrahydrocannabinol
Cannabidiol is already approved in United States, European Union, Canada for the following indications:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator