Does Medical Cannabis Reduce Opioid Use in Adults With Pain

NCT04308148 | Completed

• 1 other identifier: 2019-10029
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Marijuana; Chronic Pain

Keywords

Opioid; Marijuana; Cannabis; Pain

Outcome Measures

Primary Outcomes (1)

• Opioid analgesic use

  The primary outcome will be opioid analgesic use.

  Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.

Secondary Outcomes (1)

• Adverse events

  Adverse events will be over 14 weeks

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Laura and John Arnold Foundation: collaborator
• Vireo Health: collaborator

Study Sites (1)

Montefiore Health System

The Bronx, New York, 10451, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julia Arnsten, MD, MPH

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 13, 2020
• Study Start: October 6, 2020
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

US (1)