Back to results

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

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:

>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)

Sites / Locations

Vireo Health of New YorkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

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

NCT ID

NCT04495725

First Posted

July 28, 2020

Last Updated

June 29, 2022

Sponsor

Vireo Health

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

Studies a U.S. FDA-regulated Device Product

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

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

stephendahmer@vireohealth.com

First Name & Middle Initial & Last Name or Official Title & Degree

Olivia Uhley, BA

Phone

402-819-8955

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

stephendahmer@vireohealth.com

First Name & Middle Initial & Last Name & Degree

Olivia Uhley, BA

Phone

402-819-8955

oliviauhley@vireohealth.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs