Dosing Intervals of Opioid Medication for Chronic Pain

• Status: Withdrawn
• Trial end date: 2020-03-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Canadian Society of Hospital Pharmacists
• Treatments: Analgesics, Opioid; Hydromorphone; Morphine; Oxycodone

Criteria

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