Pain Inflammation and Cannabis in HIV
Part of paid clinical trials in The Bronx, New York.
- Sponsor
- Montefiore Medical Center
- Study ID
- NCT05554146
- Status
- Completed
Conditions
- Cannabis
- HIV Infections
- Neuropathic Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Receipt of Coupon for Placebo Soft-Gel Capsule — OTHERThe investigators will follow participants who were randomized to receive a coupon for placebo soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study Placebo (0:0) Softgel, 0mg THC and 0mg CBD per cap, Bottle of 30 caps
- Receipt of Coupon for High THC Soft-Gel Capsule — OTHERThe investigators will follow participants who were randomized to receive a coupon for high THC soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study Vireo Yellow (6:1) Softgel, 4.29mg THC and 0.72mg CBD per cap, Bottle of 30 caps
- Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule — OTHERThe investigators will follow participants who were randomized to receive a coupon for equal THC and CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study Vireo Green (1:1) Softgel, 2.5mg THC and 2.5mg CBD per cap, Bottle of 30 caps
- Receipt of Coupon for High CBD Soft-Gel Capsule — OTHERThe investigators will follow participants who were randomized to receive a coupon for high CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study Vireo Indigo (1:19) Softgel, 0.25mg THC and 4.75mg CBD per cap, Bottle of 30 caps
Study Details
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.
Key Dates
- Start date
- Oct 28, 2022
- Status verified
- Oct 2025
- Primary completion
- May 3, 2024
- Completion
- May 3, 2024
Study Design
- Enrollment
- 35 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Other: Coupon for a Discounted Placebo ProductWe will observe participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by our collaborators, Vireo.
- Other: Coupon for a Discounted High THC ProductWe will observe participants who were previously randomized to a coupon for discounted 4.29 mg THC/0.72 mg CBD soft-gel capsules by our collaborators, Vireo.
- Other: Coupon for a Discounted Equal THC and CBD ProductWe 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.
- Other: Coupon for a Discounted High CBD ProductWe will observe participants who were previously randomized to a coupon for discounted 0.25 mg THC/4.75 mg CBD soft-gel capsules by our collaborators, Vireo.
Primary Outcome Measure
Change in Pain Severity Score [ Time Frame: At weekly intervals from Baseline to 14 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Montefiore Health System | The Bronx | New York | 10467 | - |
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