Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain (ReLeaf-V)

Vireo Health

Status: Completed

Conditions: Chronic Pain; Opioid Use; Marijuana

Treatments: Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products

Study type: Interventional

Funder types: Other

Identifiers

NCT04495725

ReLeaf-V

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 270 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. >18 years old
2. English or Spanish fluency
3. active certification for medical cannabis
4. intends to have a soft-gel capsule product dispensed at Vireo Health
5. 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
6. joint or neuropathic pain
7. current severe pain
8. 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

1. inability to provide informed consent
2. inability to complete study visits over 14 weeks
3. terminal illness
4. current or prior psychotic disorder
5. current or prior buprenorphine or methadone treatment for opioid use disorder
6. NYS medical marijuana prescriber does not approve changes to product and dosing recommendations listed on the participant's certification form
7. Allergy to tapioca or coconut
8. currently pregnant, planning to become pregnant within the next 3 months, or breastfeeding
9. 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 4 patient groups, including a placebo group

Voucher for a Discounted Placebo Product

Placebo Comparator group

Description:

Voucher for a Discounted Placebo Soft-Gel Capsule Product

Treatment:

Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products

Voucher for a Discounted High THC:Low CBD Product

Experimental group

Description:

Voucher for a Discounted 4.3mg THC/0.7mg CBD Soft-Gel Capsule Product

Treatment:

Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products

Voucher for a Discounted Equal THC:CBD Product

Experimental group

Description:

Voucher for a Discounted 2.5mg THC/2.5mg CBD Soft-Gel Capsule Product

Treatment:

Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products

Voucher for a Discounted Low THC:High CBD Product

Experimental group

Description:

Voucher for a Discounted 0.2mg THC/4.8mg CBD Soft-Gel Capsule Product

Treatment:

Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products