Pain Inflammation and Cannabis in HIV
- Conditions
- CannabisNeuropathic PainHIV Infections
- Interventions
- Other: Receipt of Coupon for Placebo Soft-Gel CapsuleOther: Receipt of Coupon for High THC Soft-Gel CapsuleOther: Receipt of Coupon for Equal THC and CBD Soft-Gel CapsuleOther: Receipt of Coupon for High CBD Soft-Gel Capsule
- Registration Number
- NCT05554146
- Lead Sponsor
- Montefiore Medical Center
- Brief 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 THC (tetrahydrocannabinol) and CBD (cannabidiol) in medical cannabis impact neuropathic pain, inflammation and adverse events.
- Detailed Description
This study will examine how medical cannabis use affects neuropathic pain in PLWH with neuropathic pain. The investigators will enroll adults with HIV who have a) neuropathic pain, b) are actively certified for medical cannabis, and c) intend to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary). The investigators will observe how pain and inflammation change in participants after they are randomized to receive high THC:low CBD product, an equal THC:CBD product, a low THC:high CBD product, or placebo by our collaborator in a separate study. Over 14 weeks, data sources will include questionnaires, blood samples, urine samples; medical, pharmacy, and Prescription Monitoring Program (PMP) records. The primary independent variable will be type of medical cannabis product dispensed at dispensary, and the primary outcome will be self-reported pain.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Coupon for a Discounted Placebo Product Receipt of Coupon for Placebo Soft-Gel Capsule We will observe participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by our collaborators, Vireo. Coupon for a Discounted High THC Product Receipt of Coupon for High THC Soft-Gel Capsule We will observe participants who were previously randomized to a coupon for discounted 4.3 mg THC/0.7 mg CBD soft-gel capsules by our collaborators, Vireo. Coupon for a Discounted Equal THC and CBD Product Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule We will observe participants who were previously randomized to a coupon for discounted 2.5 mg THC/2.5 mg CBD soft-gel capsules by our collaborators, Vireo. Coupon for a Discounted High CBD Product Receipt of Coupon for High CBD Soft-Gel Capsule We will observe participants who were previously randomized to a coupon for discounted 0.2 mg THC/4.8 mg CBD soft-gel capsules by our collaborators, Vireo.
- Primary Outcome Measures
Name Time Method Pain severity 14 weeks self-reported pain severity measured via the Brief Pain Interference (BPI) severity scale (1-10) with higher score indicating worse pain. Measured weekly with web- or phone-based questionnaire.
- Secondary Outcome Measures
Name Time Method Circulating levels of inflammatory cytokines 14 weeks Tests levels of recent inflammation (panel of inflammatory markers) at two time points before starting medical cannabis and 14 weeks after starting medical cannabis. Reported in pg/mL
Anxiety 14 weeks Measured at 0 and 14 weeks with the Generalized Anxiety Disorder-7 \[GAD-7\] (0-21) with higher score indicating worse anxiety
Depression 14 weeks Measured at 0 and 14 weeks with the Patient Health Questionnaire- 9 \[PHQ-9\] (0-27) with higher score indicating worse depression
Antiretroviral adherence 14 weeks Measured at 0 and 14 weeks Visual Analog Scale \[VAS\] (0-100) with higher number indicating better adherence.
HIV Viral load suppression 14 weeks HIV viral load measured at two time points (baseline and 14 weeks; copies/mL)
Trial Locations
- Locations (1)
Montefiore Health System
🇺🇸Bronx, New York, United States