Dosing Intervals of Opioid Medication for Chronic Pain

NCT04132011 | Withdrawn Phase 4

• 1 other identifier: 17-6180
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

opioid

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who complete both treatment periods and have evaluable Patient Global Impression and pharmacokinetic data

  Feasibility outcome

  8 months

Secondary Outcomes (12)

• Patient Global Impression of Change

  3 weeks

• Numerical Pain Rating Scale

  3 weeks

• Brief Pain Inventory (Short Form)

  3 weeks

• Subjective Opioid Withdrawal Scale

  3 weeks

• Addiction Research Centre Inventory (ARCI) - short form

  8 hours

Study Arms (2)

Shortened interval extended release opioid

ACTIVE COMPARATOR

Extended release opioid, individualized total daily dose, dosing intervals less than every 12 hours.

Drug: Extended Release Opioid Formulation, Shortened Intervals; Drug: Placebo oral tablet

Standard interval extended release opioid

ACTIVE COMPARATOR

Extended release opioid, individualized total daily dose, dosing intervals every 12 hours

Drug: Extended Release Opioid Formulation, Standard intervals; Drug: Placebo oral tablet

Interventions

Extended Release Opioid Formulation, Shortened Intervals DRUG

Extended release opioid, individualized total daily dose, dosing interval is less than every 12 hours

Also known as: Hydromorphone extended release, HydromorphContin, Oxycodone controlled release, morphine sulphate sustained release, morphine slow release

Shortened interval extended release opioid

Extended Release Opioid Formulation, Standard intervals DRUG

Extended release opioid, individualized total daily dose, dosing interval is every 12 hours

Also known as: Hydromorphone extended release, HydromorphContin, Oxycodone controlled release, Morphine sulphate sustained release, morphine slow release

Standard interval extended release opioid

Placebo oral tablet DRUG

Lactose pill manufactured to mimic extended release opioid formulation

Also known as: Placebo (for Extended release opioid)

Shortened interval extended release opioid; Standard interval extended release opioid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Society of Hospital Pharmacists: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2A2, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea Furlan, MD, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility study of an n-of-1, within-subject, crossover, randomized, double blind, placebo controlled case series

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 18, 2019
• Study Start: May 1, 2019
• Primary Completion: March 8, 2020
• Study Completion: March 8, 2020
• Last Updated: March 27, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)