Pain Inflammation and Cannabis in HIV

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Medical Cannabis on Pain and Inflammation in People Living With HIV

Conditions
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HIV Infections, Neuropathic Pain, Cannabis

Intervention / Treatment
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* Other: 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will observe participants who are enrolled in one of 4 arms in a partnering study over 14 weeks.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Coupon for a Discounted Placebo Product<br>We will observe participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by our collaborators, Vireo. | Other: Receipt of Coupon for Placebo Soft-Gel Capsule<br>* The 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<br>|
| Other: Coupon for a Discounted High THC Product<br>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. | Other: Receipt of Coupon for High THC Soft-Gel Capsule<br>* The 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<br>|
| Other: Coupon for a Discounted Equal THC and CBD Product<br>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. | Other: Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule<br>* The 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<br>|
| Other: Coupon for a Discounted High CBD Product<br>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. | Other: Receipt of Coupon for High CBD Soft-Gel Capsule<br>* The 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity | 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. | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating levels of inflammatory cytokines | 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 | 14 weeks | 
| Antiretroviral adherence | Measured at 0 and 14 weeks Visual Analog Scale [VAS] (0-100) with higher number indicating better adherence. | 14 weeks | 
| HIV Viral load suppression | HIV viral load measured at two time points (baseline and 14 weeks; copies/mL) | 14 weeks | 
| Depression | Measured at 0 and 14 weeks with the Patient Health Questionnaire- 9 [PHQ-9] (0-27) with higher score indicating worse depression | 14 weeks | 
| Anxiety | Measured at 0 and 14 weeks with the Generalized Anxiety Disorder-7 [GAD-7] (0-21) with higher score indicating worse anxiety | 14 weeks |