Does Medical Cannabis Reduce Opioid Use in Adults With Pain

NCT ID: NCT04308148

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

217 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-06

Study Completion Date

2024-03-13

Brief Summary

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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

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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.

Conditions

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Opioid Use Marijuana Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laura and John Arnold Foundation

OTHER

Sponsor Role collaborator

Vireo Health

OTHER

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julia Arnsten, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Montefiore Health System

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2019-10029

Identifier Type: -

Identifier Source: org_study_id

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