Does Medical Cannabis Reduce Opioid Use in Adults With Pain

Last updated: March 21, 2024
Sponsor: Albert Einstein College of Medicine
Overall Status: Completed

Phase

N/A

Condition

Pain

Chronic Pain

Substance Abuse

Treatment

N/A

Clinical Study ID

NCT04308148
2019-10029
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 useor 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 topotential participants.

Exclusion

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, orbreastfeeding
  • Condition that is considered by a pharmacist or medical provider to be acontraindication to medical cannabis use (e.g. unstable cardiac arrhythmia or specificdrug-use interaction)

Study Design

Total Participants: 217
Study Start date:
October 06, 2020
Estimated Completion Date:
March 13, 2024

Study 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.

Connect with a study center

  • Montefiore Health System

    Bronx, New York 10451
    United States

    Site Not Available

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