Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain

Study Overview
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Brief Summary
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This study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. Our study findings will have critically important implications to shape clinical care and medical cannabis policies.

Detailed Description
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This study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. ReLeaf-V is a 4-arm blinded randomized controlled trial (RCT) of 352 adults with (a) severe or chronic neuropathic or joint pain, (b) opioid analgesic use, and (c) active certification for medical cannabis. We will randomize participants to a discounted voucher for: 1) a placebo soft-gel capsule product, 2) high THC:low CBD soft-gel capsule product (4.3mg THC/0.7mg CBD), 3) equal THC:CBD soft-gel capsule product (2.5mg THC/2.5mg CBD), or 4) low THC:high CBD soft-gel capsule product (0.2mg THC/4.8mg CBD). Over 14 weeks, participants will have 5 research visits in which data will be collected from questionnaires, and medical and Prescription Monitoring Program (PMP) records. The primary independent variable will be randomization arm, and the primary outcome will be cumulative opioid analgesic dose.

Official Title
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Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain: A Randomized Controlled Trial (The ReLeaf-V Study)

Conditions
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Opioid Use, Marijuana, Chronic Pain

Intervention / Treatment
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* Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years old English or Spanish fluency active certification for medical cannabis intends to have a soft-gel capsule product dispensed at Vireo Health medical cannabis qualifying conditions or complications of (a) chronic pain, or (b) pain that degrades health and functional capability as an alternative to opioid use or substance use disorder or (c) severe or chronic pain joint or neuropathic pain current severe pain dispensed opioids analgesics within the last 60 days To maintain the integrity of the study, we do not disclose all inclusion criteria to potential participants. Exclusion Criteria: inability to provide informed consent inability to complete study visits over 14 weeks terminal illness current or prior psychotic disorder current or prior buprenorphine or methadone treatment for opioid use disorder NYS medical marijuana prescriber does not approve changes to product and dosing recommendations listed on the participant's certification form Allergy to tapioca or coconut currently pregnant, planning to become pregnant within the next 3 months, or breastfeeding a condition that is considered by a pharmacist or medical provider to be a clinical contraindication to medical cannabis use (e.g. unstable cardiac arrhythmia or specific drug-drug interaction)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Voucher for a Discounted Placebo Product<br>Voucher for a Discounted Placebo Soft-Gel Capsule Product | Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products<br>* We will randomize participants to one of the following four conditions for discounted vouchers: 1) a discounted voucher for a placebo soft-gel capsule product, 2) a discounted voucher for a high THC:low CBD soft-gel capsule product, 3) a discounted voucher for an equal THC:CBD soft-gel capsule product, or 4) a discounted voucher for a low THC:high CBD soft-gel capsule product. We will stratify randomization by history of cannabis use (no use in the past year, used in the past year and not near-daily or daily (used in the past year and <20 days out of the last 30 days), near-daily or daily (>= 20 days out of the last 30 days) baseline opioid analgesic prescription (chronic opioid treatment vs. not chronic opioid use), and primary pain condition (neuropathy, not neuropathy). Chronic opioid treatment is defined as prescribed opioids ≥90 non-overlapping days in the past 182 days. Randomization will occur in blocks to ensure equal randomization over time.<br>|
| Experimental: Voucher for a Discounted High THC:Low CBD Product<br>Voucher for a Discounted 4.3mg THC/0.7mg CBD Soft-Gel Capsule Product | Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products<br>* We will randomize participants to one of the following four conditions for discounted vouchers: 1) a discounted voucher for a placebo soft-gel capsule product, 2) a discounted voucher for a high THC:low CBD soft-gel capsule product, 3) a discounted voucher for an equal THC:CBD soft-gel capsule product, or 4) a discounted voucher for a low THC:high CBD soft-gel capsule product. We will stratify randomization by history of cannabis use (no use in the past year, used in the past year and not near-daily or daily (used in the past year and <20 days out of the last 30 days), near-daily or daily (>= 20 days out of the last 30 days) baseline opioid analgesic prescription (chronic opioid treatment vs. not chronic opioid use), and primary pain condition (neuropathy, not neuropathy). Chronic opioid treatment is defined as prescribed opioids ≥90 non-overlapping days in the past 182 days. Randomization will occur in blocks to ensure equal randomization over time.<br>|
| Experimental: Voucher for a Discounted Equal THC:CBD Product<br>Voucher for a Discounted 2.5mg THC/2.5mg CBD Soft-Gel Capsule Product | Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products<br>* We will randomize participants to one of the following four conditions for discounted vouchers: 1) a discounted voucher for a placebo soft-gel capsule product, 2) a discounted voucher for a high THC:low CBD soft-gel capsule product, 3) a discounted voucher for an equal THC:CBD soft-gel capsule product, or 4) a discounted voucher for a low THC:high CBD soft-gel capsule product. We will stratify randomization by history of cannabis use (no use in the past year, used in the past year and not near-daily or daily (used in the past year and <20 days out of the last 30 days), near-daily or daily (>= 20 days out of the last 30 days) baseline opioid analgesic prescription (chronic opioid treatment vs. not chronic opioid use), and primary pain condition (neuropathy, not neuropathy). Chronic opioid treatment is defined as prescribed opioids ≥90 non-overlapping days in the past 182 days. Randomization will occur in blocks to ensure equal randomization over time.<br>|
| Experimental: Voucher for a Discounted Low THC:High CBD Product<br>Voucher for a Discounted 0.2mg THC/4.8mg CBD Soft-Gel Capsule Product | Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products<br>* We will randomize participants to one of the following four conditions for discounted vouchers: 1) a discounted voucher for a placebo soft-gel capsule product, 2) a discounted voucher for a high THC:low CBD soft-gel capsule product, 3) a discounted voucher for an equal THC:CBD soft-gel capsule product, or 4) a discounted voucher for a low THC:high CBD soft-gel capsule product. We will stratify randomization by history of cannabis use (no use in the past year, used in the past year and not near-daily or daily (used in the past year and <20 days out of the last 30 days), near-daily or daily (>= 20 days out of the last 30 days) baseline opioid analgesic prescription (chronic opioid treatment vs. not chronic opioid use), and primary pain condition (neuropathy, not neuropathy). Chronic opioid treatment is defined as prescribed opioids ≥90 non-overlapping days in the past 182 days. Randomization will occur in blocks to ensure equal randomization over time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid analgesic use | The primary outcome will be cumulative opioid analgesic dose. | Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, opioid, marijuana, cannabis