Clinical trial NCT04132011: Dosing Intervals of Opioid Medication for Chronic Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Pain
Keywords: opioid
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Society of Hospital Pharmacists
First posted: 2019-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Feasibility study of an n-of-1, within-subject, crossover, randomized, double blind, placebo controlled case series
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percentage of participants who complete both treatment periods and have evaluable Patient Global Impression and pharmacokinetic data
timeFrame: 8 months
Secondary outcomes:
measure: Patient Global Impression of Change
timeFrame: 3 weeks
measure: Numerical Pain Rating Scale
timeFrame: 3 weeks
measure: Brief Pain Inventory (Short Form)
timeFrame: 3 weeks
measure: Subjective Opioid Withdrawal Scale
timeFrame: 3 weeks
measure: Addiction Research Centre Inventory (ARCI) - short form
timeFrame: 8 hours
measure: Profile of Mood States
timeFrame: 8 hours
measure: Visual analogue scale - liking/high
timeFrame: 8 hours
measure: Serum opioid concentrations
timeFrame: 6 hours
measure: Peak plasma concentration (Cmax)
timeFrame: 6 hours
measure: Time to peak plasma concentration (Tmax)
timeFrame: 6 hours
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 24 hours
measure: Abuse liability quotient (AQ)
timeFrame: 6 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Principal Investigator
name: Andrea Furlan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: