Does Medical Cannabis Reduce Opioid Use in Adults With Pain

Chronic Pain Clinical Trial

— ReLeaf-E  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04308148
• Other study ID #: 2019-10029
• Status: Completed
• Start date: October 6, 2020
• Est. completion date: March 13, 2024

Study information

• Verified date: March 2024
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: March 13, 2024
• Est. primary completion date: March 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Marijuana
• Marijuana Abuse
• Opioid Use

Locations

Country	Name	City	State
United States	Montefiore Health System	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	Laura and John Arnold Foundation, Vireo Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events	(e.g. Cannabis use disorder, illicit drug use, diversion of medical cannabis, accidents and injuries)	Adverse events will be over 14 weeks