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

March 21, 2024 updated by: Albert Einstein College of Medicine

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10451
        • Montefiore Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with chronic pain, who are taking opioids and are actively certified for medical cannabis in New York.

Description

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
  • Buprenorphine or methadone treatment for opioid use disorder within the past year
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid analgesic use
Time Frame: Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.
The primary outcome will be opioid analgesic use.
Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Adverse events will be over 14 weeks
(e.g. Cannabis use disorder, illicit drug use, diversion of medical cannabis, accidents and injuries)
Adverse events will be over 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

Laura and John Arnold Foundation
Vireo Health

Investigators

  • Principal Investigator: Julia Arnsten, MD, MPH, Albert Einstein College Of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2020

Primary Completion (Actual)

March 13, 2024

Study Completion (Actual)

March 13, 2024

Study Registration Dates

First Submitted

March 12, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-10029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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