Dosing Intervals of Opioid Medication for Chronic Pain

Examining the Relationship Amongst Opioid Subjective Effects and Pharmacokinetics of Extended Release Opioids at Shortened Dosing Intervals in Patients With Chronic Pain: a Randomized, Blinded, N-of-1 Case Series Feasibility Study

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.

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