N/A
N=34
Pain Inflammation and Cannabis in HIV
HIV Infections · Neuropathic Pain · Cannabis
Bottom Line
View on ClinicalTrials.gov: NCT05554146 ↗Enrolled (actual)
34
Serious AEs
8.8%
Results posted
Nov 2025
Primary outcome: Primary: Change in Pain Severity Score — 6.44; 6.86; 8; 7.37 score on a scale — p=0.0303
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Receipt of Coupon for Placebo Soft-Gel Capsule (Other); Receipt of Coupon for High THC Soft-Gel Capsule (Other); Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule (Other); Receipt of Coupon for High CBD Soft-Gel Capsule (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Severity Score |
6.44; 6.86; 8; 7.37; 5.87; 6.67 | 0.0303 sig |
| SECONDARY Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-10 (IL-10) |
0.15; 0.41; 0.11; 0.65 | 0.6 |
| SECONDARY Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-4 (IL-4) |
-0.33; -0.21; 0.02; 0.07 | 0.49 |
| SECONDARY Change in Circulating Levels of Pro-inflammatory Cytokines - Tumor Necrosis Factor Alpha (TNFa) |
-0.02; 0.03; 0.05; -0.18 | 0.66 |
| SECONDARY Change in Circulating Levels of Pro-inflammatory Cytokines - Interleukin-6 (IL-6) |
0.24; 0.11; -0.18; -0.09 | 0.88 |
| SECONDARY Change in Antiretroviral Medication Adherence Score |
-1; 0; 2; 1 | 0.39 |
| SECONDARY Change in HIV Viral Load Suppression |
-12270.43; 7.7; -5; 3737 | 0.31 |
| SECONDARY Change in Depression Score |
-9.71; -9; -3.56; -2.25 | 0.13 |
| SECONDARY Change in Anxiety Score |
-5.71; -1.43; -1.75; -1.12 | 0.22 |
Summary
This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. The investigators will observe how varying ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD) in medical cannabis impact neuropathic pain, inflammation and adverse events.
Eligibility Criteria
Inclusion criteria
->=18 years old
- Diagnosis of HIV
- Fluency in English
- Active certification for medical cannabis
- ICD-10 diagnosis code for neuropathic pain, OR Neuropathic pain in problem list of electronic medical record, OR Neuropathic pain per medical cannabis certification form, OR Neuropathic Pain Questionnaire-Short Form>0
Exclusion Criteria
- Inability to provide informed consent
- Inability to complete 14 weeks of study visits
- Medical cannabis use within 14 days of enrollment, and no medical cannabis dispensed within 30 days of enrollment
- Unique pain symptoms (e.g., multiple sclerosis, rheumatoid arthritis)
- Terminal illness
- Current or prior psychotic disorder
- Unregulated cannabis use in the past 14 days; opioid or cocaine use in the past 30 days
- Dispensed opioids within 30 days
- Non-steroidal anti-inflammatory use within 7 days prior to enrollment
- Steroid use within the past 14 days with duration of therapy >=21 days
- COVID vaccination or booster within 14 days of screening
- Active or acute cardiac disease based on clinician chart review.
Data sourced from ClinicalTrials.gov (NCT05554146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.