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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04495725
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Vireo Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Opioid Use Marijuana Chronic Pain Other: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain: A Randomized Controlled Trial (The ReLeaf-V Study)
Actual Study Start Date : October 6, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495725


Contacts
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Contact: Stephen Dahmer, MD 612-999-1606 stephendahmer@vireohealth.com
Contact: Olivia Uhley, BA 402-819-8955 oliviauhley@vireohealth.com

Locations
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United States, New York
Vireo Health of New York Recruiting
Queens, New York, United States, 11373
Contact: Stephen Dahmer, MD    612-999-1606    stephendahmer@vireohealth.com   
Contact: Olivia Uhley, BA    402-819-8955    oliviauhley@vireohealth.com   
Sponsors and Collaborators
Vireo Health
Investigators
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Principal Investigator: Stephen Dahmer, MD Vireo Health of New York
More Information
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Responsible Party: Vireo Health
ClinicalTrials.gov Identifier: NCT04495725    
Other Study ID Numbers: ReLeaf-V
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vireo Health:
opioid
marijuana
cannabis
pain
Additional relevant MeSH terms:
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Chronic Pain
Marijuana Abuse
Pain
Neurologic Manifestations
 Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders