Dosing Intervals of Opioid Medication for Chronic Pain
WithdrawnPhase 4NCT04132011
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Drug: Extended Release Opioid Formulation, Shortened Intervals
- Drug: Extended Release Opioid Formulation, Standard intervals
- Drug: Placebo oral tablet
- Sponsor
- University Health Network, Toronto
- Collaborators
- Canadian Society of Hospital Pharmacists
- Start date
- 2019-05-01
- Primary completion
- 2020-03-08
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04132011