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OpenTrials
Completed

NCT Number: NCT04308148

Does Medical Cannabis Reduce Opioid Use in Adults With Pain

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Health System

The Bronx, New York, 10451, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • Laura and John Arnold Foundation
  • Vireo Health

Registry information

Official study title

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

Acronym: ReLeaf-E

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2020
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.