Study Results
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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WITHDRAWN
PHASE4
INTERVENTIONAL
2019-05-01
2020-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Shortened interval extended release opioid
Extended release opioid, individualized total daily dose, dosing intervals less than every 12 hours.
Extended Release Opioid Formulation, Shortened Intervals
Extended release opioid, individualized total daily dose, dosing interval is less than every 12 hours
Placebo oral tablet
Lactose pill manufactured to mimic extended release opioid formulation
Standard interval extended release opioid
Extended release opioid, individualized total daily dose, dosing intervals every 12 hours
Extended Release Opioid Formulation, Standard intervals
Extended release opioid, individualized total daily dose, dosing interval is every 12 hours
Placebo oral tablet
Lactose pill manufactured to mimic extended release opioid formulation
Interventions
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Extended Release Opioid Formulation, Shortened Intervals
Extended release opioid, individualized total daily dose, dosing interval is less than every 12 hours
Extended Release Opioid Formulation, Standard intervals
Extended release opioid, individualized total daily dose, dosing interval is every 12 hours
Placebo oral tablet
Lactose pill manufactured to mimic extended release opioid formulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* willing and capable to give written informed consent
* diagnosis of chronic pain (\> 3 months)
* current prescription for oxycodone controlled release or hydromorphone controlled release or morphine sustained release for pain
* Using extended release opioids at intervals less than 12 hours/ more than twice daily
Exclusion Criteria
* use of immediate release opioids that contribute to more than 20% of their total daily opioid dose
* total daily morphine equivalent dose \>400mg
* actively tapering their opioid dose
* use of multiple extended release opioid products
* unstable psychological diagnosis (using the Psychosocial Screening Interview Guide)
* outstanding or planned litigation related to pain
* pregnancy or lactation in women
* history of coronary artery disease
* active tapering or titration of benzodiazepines or cannabinoids
* positive urine drug screen for amphetamines, barbiturates, cocaine, methamphetamine, methadone, phencyclidine, propoxyphene or unexpected opioids or benzodiazepines
* using M-Eslon
* using long acting hydromorphone
* using Kadian
18 Years
ALL
No
Sponsors
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Canadian Society of Hospital Pharmacists
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Andrea Furlan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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University Health Network
Toronto, Ontario, Canada
Countries
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Other Identifiers
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17-6180
Identifier Type: -
Identifier Source: org_study_id
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