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

Primary Purpose

Opioid Use, Marijuana, Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products
Sponsored by
Vireo Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use focused on measuring opioid, marijuana, cannabis, pain

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vireo Health of New YorkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Voucher for a Discounted Placebo Product

Voucher for a Discounted High THC:Low CBD Product

Voucher for a Discounted Equal THC:CBD Product

Voucher for a Discounted Low THC:High CBD Product

Arm Description

Voucher for a Discounted Placebo Soft-Gel Capsule Product

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

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

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

Outcomes

Primary Outcome Measures

Opioid analgesic use
The primary outcome will be cumulative opioid analgesic dose.

Secondary Outcome Measures

Full Information

First Posted
July 28, 2020
Last Updated
June 29, 2022
Sponsor
Vireo Health
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1. Study Identification

Unique Protocol Identification Number
NCT04495725
Brief Title
Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain
Acronym
ReLeaf-V
Official Title
Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain: A Randomized Controlled Trial (The ReLeaf-V Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vireo Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Marijuana, Chronic Pain
Keywords
opioid, marijuana, cannabis, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
352 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Voucher for a Discounted Placebo Product
Arm Type
Placebo Comparator
Arm Description
Voucher for a Discounted Placebo Soft-Gel Capsule Product
Arm Title
Voucher for a Discounted High THC:Low CBD Product
Arm Type
Experimental
Arm Description
Voucher for a Discounted 4.3mg THC/0.7mg CBD Soft-Gel Capsule Product
Arm Title
Voucher for a Discounted Equal THC:CBD Product
Arm Type
Experimental
Arm Description
Voucher for a Discounted 2.5mg THC/2.5mg CBD Soft-Gel Capsule Product
Arm Title
Voucher for a Discounted Low THC:High CBD Product
Arm Type
Experimental
Arm Description
Voucher for a Discounted 0.2mg THC/4.8mg CBD Soft-Gel Capsule Product
Intervention Type
Other
Intervention Name(s)
Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opioid analgesic use
Description
The primary outcome will be cumulative opioid analgesic dose.
Time Frame
Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >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 Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Dahmer, MD
Phone
612-999-1606
Email
stephendahmer@vireohealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Uhley, BA
Phone
402-819-8955
Email
oliviauhley@vireohealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Dahmer, MD
Organizational Affiliation
Vireo Health of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vireo Health of New York
City
Queens
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Dahmer, MD
Phone
612-999-1606
Email
stephendahmer@vireohealth.com
First Name & Middle Initial & Last Name & Degree
Olivia Uhley, BA
Phone
402-819-8955
Email
oliviauhley@vireohealth.com

12. IPD Sharing Statement

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

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