Clinical trial NCT04495725: Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain
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
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Marijuana
Chronic Pain
Keywords: opioid
marijuana
cannabis
pain
Lead sponsor: Vireo Health
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Opioid analgesic use
timeFrame: Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Queens
country: United States
facility: Vireo Health of New York
state: New York
Study officials:
affiliation: Vireo Health of New York
name: Stephen Dahmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Giovanna DiFrancesca
role: STUDY_DIRECTOR
References: