Does Medical Cannabis Reduce Opioid Use in Adults With Pain
Keywords
Abstract
Description
This study will examine how medical cannabis use affects opioid analgesic use, with particular attention to THC/CBD content and adverse events. We will enroll adults with (a) severe or chronic neuropathic or joint pain, (b) prescribed opioid analgesic use, (c) new certification for medical cannabis, and (d) newly dispensed soft gel capsule products from Vireo (medical cannabis dispensary) (including a high THC:low CBD product, an equal THC:CBD 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.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 03/11/2020 |
| Estimated Enrollment Submitted: | 03/11/2020 |
| First Posted: | 03/12/2020 |
| Last Update Submitted: | 07/15/2020 |
| Last Update Posted: | 07/16/2020 |
| Actual Study Start Date: | 07/30/2020 |
| Estimated Primary Completion Date: | 12/30/2022 |
| Estimated Study Completion Date: | 12/30/2022 |
Condition or disease
Phase
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - At least 18 years of age - English or Spanish fluency - New certification for medical cannabis within 90 days - No medical cannabis dispensed or used within the previous 6 months - New 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 30 days - Self-reported use of opioid analgesics Exclusion Criteria: - Inability to provide informed consent - Inability to complete study visits over 14 weeks - Qualifying conditions for medical cannabis in NY that are likely to cause unique pain syndromes - Terminal illness - Current or prior psychotic disorder - Current or prior buprenorphine or methadone treatment for opioid use disorder - Allergies to tapioca or coconut |
Outcome
Primary Outcome Measures
1. Opioid analgesic use [Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.]
Secondary Outcome Measures
1. Adverse events [Adverse events will be over 14 weeks]
