Does Medical Cannabis Reduce Opioid Use in Adults With Pain

Study Overview
=================
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.

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.

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

Conditions
-----------------
Opioid Use, Marijuana, Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid, Marijuana, Cannabis, Pain