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

NCT04495725 | Completed DMC

• 1 other identifier: ReLeaf-V
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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 shape clinical care and medical cannabis policies.

Conditions

Opioid Use; Marijuana; Chronic Pain

Keywords

opioid; marijuana; cannabis; pain

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Voucher for a Discounted Placebo Product

PLACEBO COMPARATOR

Voucher for a Discounted Placebo Soft-Gel Capsule Product

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

Voucher for a Discounted High THC:Low CBD Product

EXPERIMENTAL

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

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

Voucher for a Discounted Equal THC:CBD Product

EXPERIMENTAL

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

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

Voucher for a Discounted Low THC:High CBD Product

EXPERIMENTAL

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

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

Interventions

Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products OTHER

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.

Voucher for a Discounted Equal THC:CBD Product; Voucher for a Discounted High THC:Low CBD Product; Voucher for a Discounted Low THC:High CBD Product; Voucher for a Discounted Placebo Product

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vireo Health: lead

Study Sites (1)

Vireo Health of New York

Queens, New York, 11373, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Dahmer, MD

  Vireo Health of New York

  PRINCIPAL INVESTIGATOR

• Giovanna DiFrancesca

  Albert Einstein College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 3, 2020
• Study Start: October 6, 2020
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)