Does Medical Cannabis Reduce Opioid Use in Adults With Pain (ReLeaf-E)

Albert Einstein College of Medicine

Status: Completed

Conditions: Chronic Pain; Opioid Use; Marijuana

Study type: Observational

Funder types: Other

Identifiers

NCT04308148

2019-10029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 217 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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)