Clinical trial NCT04308148: Does Medical Cannabis Reduce Opioid Use in Adults With Pain
Official title: Does Medical Cannabis Reduce Opioid Use in Adults With Pain: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use
Marijuana
Chronic Pain
Keywords: Opioid
Marijuana
Cannabis
Pain
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Laura and John Arnold Foundation
name: Vireo Health
First posted: 2020-03-13
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with chronic pain, who are taking opioids and are actively certified for medical cannabis in New York.

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.

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)

Primary outcomes:
measure: Opioid analgesic use
timeFrame: Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.
Secondary outcomes:
measure: Adverse events
timeFrame: Adverse events will be over 14 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Health System
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Julia Arnsten, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: