Status:

COMPLETED

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

Lead Sponsor:

Vireo Health

Conditions:

Opioid Use

Marijuana

Eligibility:

All Genders

18-99 years

Phase:

NA

Brief Summary

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 sha...

Detailed 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 ...

Eligibility Criteria

Inclusion

  • \>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

  • 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)

Key Trial Info

Start Date :

October 6 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 13 2024

Estimated Enrollment :

270 Patients enrolled

Trial Details

Trial ID

NCT04495725

Start Date

October 6 2020

End Date

March 13 2024

Last Update

March 26 2024

Active Locations (1)

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Vireo Health of New York

Queens, New York, United States, 11373