ReLeaf-E: Does Medical Cannabis Reduce Opioid Use in Adults With Pain

Sponsor

Albert Einstein College of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04308148

Collaborator

Laura and John Arnold Foundation (Other), Vireo Health (Other)

352

Enrollment

Location

36.8

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will examine how medical cannabis use affects opioid analgesic use. This landmark study will be among the first to examine the effect of medical cannabis with different THC/CBD (Tetrahydrocannibinol/Cannabidiol) content on opioid use as well as adverse events.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Marijuana Chronic Pain

Detailed Description

This study will examine how medical cannabis use affects opioid analgesic use, with particular attention to THC/CBD (Tetrahydrocannibinol/Cannabidiol) content and adverse events. We will enroll adults with (a) severe or chronic neuropathic or joint pain, (b) prescribed opioid analgesic use, (c) active certification for medical cannabis, and (d) intends to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary) (including a high THC:low CBD product, an equal THC:CBD (Tetrahydrocannibinol:Cannabidiol) product, and a low THC:high CBD product). Over the 14 weeks, data sources will include questionnaires; medical, pharmacy, and Prescription Monitoring Program (PMP) records; and urine samples. The primary independent variable will be type of soft gel capsule product, and the primary outcome will be cumulative opioid analgesic dose.

Study Design

Study Type:

Observational

Anticipated Enrollment :

352 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Does Medical Cannabis Reduce Opioid Use in Adults With Pain: An Observational Study

Actual Study Start Date :

Oct 6, 2020

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Outcome Measures

Primary Outcome Measures

Opioid analgesic use [Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.]
The primary outcome will be opioid analgesic use.

Secondary Outcome Measures

Adverse events [Adverse events will be over 14 weeks]
(e.g. Cannabis use disorder, illicit drug use, diversion of medical cannabis, accidents and injuries)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

At least 18 years of age
English or Spanish fluency
Actively certified for medical cannabis
Intends to have a soft-gel capsule product dispensed at Vireo
Medical cannabis qualifying conditions or complications of "chronic or severe pain" or "pain that degrades health and functional capability as an alternative to opioid use or substance use disorder"
Joint or neuropathic pain
Current severe pain
Dispensed opioid 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
Allergies to tapioca or coconut
Currently pregnant, planning to become pregnant within the next 3 months, or breastfeeding
Condition that is considered by a pharmacist or medical provider to be a contraindication to medical cannabis use (e.g. unstable cardiac arrhythmia or specific drug-use interaction)