ClinicalTrials.Veeva

Menu

Dosing Intervals of Opioid Medication for Chronic Pain

University Health Network, Toronto logo

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Withdrawn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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems