Does Medical Cannabis Reduce Opioid Use in Adults With Pain | NCT04308148

Studies
Does Medical Cannabis Reduce Opioid Use in Adults With Pain

NCT04308148

Sponsor

Albert Einstein College of Medicine

Status

Completed

Last Update Posted

Mar 25, 2024Actual

Enrollment

217Actual

Phase

Not provided

Conditions

Opioid Use
Marijuana
Chronic Pain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 6, 2020Actual

Primary Completion Date

Mar 13, 2024Actual

Completion Date

Mar 13, 2024Actual

First Submitted Date

Mar 12, 2020

First Submission Date that Met QC Criteria

Mar 12, 2020

First Posted Date

Mar 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2024

Last Update Posted Date

Mar 25, 2024Actual

Name	Class
Laura and John Arnold Foundation	OTHER
Vireo Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

217Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Adults with chronic pain, who are taking opioids and are actively certified for medical cannabis in New York.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Julia Arnsten, MD, MPH	Albert Einstein College of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Montefiore Health System		The Bronx	New York	10451	United States

Condition Browse Module

MeSH Terms

ID	Term
D002189	Marijuana Abuse
D059350	Chronic Pain
D010146	Pain

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D009461	Neurologic Manifestations

Browse Leaves

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Browse Branches

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