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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Opioid Use; Marijuana
• Intervention / Treatment: Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products

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 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.

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Queens, New York, United States, 11373
      • Vireo Health of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Voucher for a Discounted Placebo Product; Voucher for a Discounted Placebo Soft-Gel Capsule Product	Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products; 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.
Experimental: Voucher for a Discounted High THC:Low CBD Product; Voucher for a Discounted 4.3mg THC/0.7mg CBD Soft-Gel Capsule Product	Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products; 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.
Experimental: Voucher for a Discounted Equal THC:CBD Product; Voucher for a Discounted 2.5mg THC/2.5mg CBD Soft-Gel Capsule Product	Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products; 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.
Experimental: Voucher for a Discounted Low THC:High CBD Product; Voucher for a Discounted 0.2mg THC/4.8mg CBD Soft-Gel Capsule Product	Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Vireo Health
• Investigators: Principal Investigator: Stephen Dahmer, MD, Vireo Health of New York; Study Director: Giovanna DiFrancesca, Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2020
• Primary Completion (Actual): March 13, 2024
• Study Completion (Actual): March 13, 2024

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: opioid; pain; cannabis; marijuana
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Chronic Pain; Marijuana Abuse
• Other Study ID Numbers: ReLeaf-V

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No