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

March 6, 2026 updated by: Vireo Health

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opioid analgesic use
Time Frame: Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vireo Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen Dahmer, MD, Vireo Health of New York
  • Study Director: Giovanna DiFrancesca, Albert Einstein College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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