Does Medical Cannabis Reduce Opioid Use in Adults With Pain

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04308148

Acronym

ReLeaf-E

Enrollment

217

Registered

2020-03-13

Start date

2020-10-06

Completion date

2024-03-13

Last updated

2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Marijuana, Opioid Use

Keywords

Opioid, Marijuana, Cannabis, Pain

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Opioid analgesic use	Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.	The primary outcome will be opioid analgesic use.

Secondary

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

Countries

United States

Outcome results