Dosing Intervals of Opioid Medication for Chronic Pain

University Health Network, Toronto

Status and phase: Withdrawn; Phase 4

Conditions: Chronic Pain

Treatments: Drug: Extended Release Opioid Formulation, Shortened Intervals; Drug: Placebo oral tablet; Drug: Extended Release Opioid Formulation, Standard intervals

Study type: Interventional

Funder types: Other

Identifiers

NCT04132011

17-6180

Details and patient eligibility

About

This study is to determine the feasibility of an n-of-1, randomized, double blind, placebo controlled case series to examine effects of extended release opioids when used at intervals shorter than recommended by the manufacturer by people with chronic pain.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 years old
• 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

• ongoing acute pain episode
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Shortened interval extended release opioid

Active Comparator group

Description:

Extended release opioid, individualized total daily dose, dosing intervals less than every 12 hours.

Treatment:

Drug: Placebo oral tablet

Drug: Extended Release Opioid Formulation, Shortened Intervals

Standard interval extended release opioid

Active Comparator group

Description:

Extended release opioid, individualized total daily dose, dosing intervals every 12 hours

Treatment:

Drug: Extended Release Opioid Formulation, Standard intervals

Drug: Placebo oral tablet