Trial results for the study "Pain Inflammation and Cannabis in HIV" were posted on ClinicalTrials.gov on 2025-11-13. The study, which enrolled 35 participants, investigated how varying ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD) in medical cannabis affect neuropathic pain in people living with HIV (PLWH). A key finding indicated that participants randomized to coupons for high THC products experienced a statistically significant reduction in self-reported pain severity compared to other groups (p=0.0303).
Background
People living with HIV (PLWH) often experience chronic neuropathic pain, a debilitating condition that can significantly impact quality of life. Current treatment options for HIV-associated neuropathic pain can be limited in efficacy or associated with undesirable side effects. This creates a need for alternative or adjunctive therapies. Cannabis, with its known analgesic properties, has been explored as a potential treatment, but the specific effects of different THC and CBD ratios on neuropathic pain and inflammation in PLWH require further investigation. This study aimed to observe these impacts and contribute to understanding the role of medical cannabis in this population.
Trial design
This completed study, designated as Phase NA, enrolled 35 participants. The trial focused on individuals with HIV Infections and Neuropathic Pain, examining the effects of Cannabis. Participants were randomized to receive coupons for discounted products, categorized as: "Coupon for a Discounted Placebo Product," "Coupon for a Discounted High THC Product," "Coupon for a Discounted Equal THC and CBD Product," and "Coupon for a Discounted High CBD Product." The study's objective was to observe how these varying ratios of THC and CBD in medical cannabis impact neuropathic pain, inflammation, and adverse events.
Key results
The trial reported several key measurements for the "Change in Pain Severity Score" across the different product groups:
- For the "Coupon for a Discounted Placebo Product" group, mean pain severity scores were 6.44 (Standard Deviation 2.07), 5.87 (Standard Deviation 3.09), and 5.22 (Standard Deviation 3.15) on a scale.
- For the "Coupon for a Discounted High THC Product" group, mean pain severity scores were 6.86 (Standard Deviation 2.27), 6.67 (Standard Deviation 2.58), and 5.86 (Standard Deviation 2.23) on a scale.
- For the "Coupon for a Discounted Equal THC and CBD Product" group, mean pain severity scores were 8 (Standard Deviation 2.38), 7.37 (Standard Deviation 1.76), and 7.57 (Standard Deviation 2.25) on a scale.
- For the "Coupon for a Discounted High CBD Product" group, mean pain severity scores were 7.37 (Standard Deviation 2.5), 6.75 (Standard Deviation 2.43), and 6.37 (Standard Deviation 2.92) on a scale.
Key analyses revealed:
- A Mixed Models Analysis indicated that participants randomized to coupons for high THC products had a greater reduction in self-reported pain severity than high CBD, equal parts THC and CBD, or placebo. This analysis yielded a Beta value of -2.6185 with a 95.0% confidence interval of -4.98 to -0.25, and a statistically significant p-value of 0.0303.
- Further Mixed Models Analyses comparing high THC products to other groups for pain severity showed a Beta value of -0.8424 with a p-value of 0.4851, and a Beta value of -0.6038 with a p-value of 0.6165.
- ANOVA analyses for anti-inflammatory cytokines (IL-4 and IL-10) showed F values of 0.63 (p-value of 0.6) and 0.83 (p-value of 0.49), respectively.
- An ANOVA analysis for pro-inflammatory cytokines (TNFa and IL-6) showed an F value of 0.53 (p-value of 0.66).
What this means
The results suggest that high THC medical cannabis products may offer a statistically significant benefit in reducing self-reported neuropathic pain severity for people living with HIV, as indicated by the p-value of 0.0303. This finding, while from a study with a relatively small enrollment of 35 participants, provides preliminary evidence supporting the potential role of THC-dominant cannabis in managing this specific type of pain. However, the study's design involving coupons for discounted products, rather than direct administration, suggests an observational component regarding actual product use. Further research with larger cohorts and controlled administration methods would be beneficial to confirm these findings and explore the long-term implications for pain management and inflammation in PLWH. The analyses for inflammatory cytokines did not show statistically significant differences across the groups.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05554146, titled "Pain Inflammation and Cannabis in HIV", were posted on 2025-11-13 on clinicaltrials.gov.