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Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT02824276
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : January 28, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Robert Edwards, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE June 28, 2016
First Posted Date  ICMJE July 6, 2016
Last Update Posted Date January 28, 2021
Actual Study Start Date  ICMJE January 6, 2017
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2016)
Changes in Pain Sensitivity (Quantitative Sensory Testing) [ Time Frame: 6 months ]
Pain Sensitivity will be assessed by Quantitative Sensory testing
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
Official Title  ICMJE Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
Brief Summary

Chronic low back pain (CLBP) afflicts up to 50 million U.S. adults and is a primary cause of disability and reduced quality of life. The prescription of opioids for chronic low back pain (CLBP) has increased substantially within the past decade in the U.S. As noted by the CDC in their recent Guideline (released in March 2016): "Opioids are commonly prescribed for pain. An estimated 20% of patients presenting to physician offices with noncancer pain symptoms or pain-related diagnoses (including acute and chronic pain) receive an opioid prescription. Interestingly, patients scoring very high on measures of psychological distress tend to be systematically excluded from RCTs, even though this subgroup of patients is highly prevalent within the chronic pain population.

This study will provide key information on individual differences in the outcomes of opioid treatment, and its findings should facilitate more effective tailoring of analgesic regimens to individual patient characteristic.

Detailed Description

Changes in pain sensitivity will be examined (i.e., OIH) among subgroups of CLBP patients prescribed oral opioid therapy.

Investigators will conduct a moderate-term, double-blind, randomized controlled trial, and use quantitative sensory testing (QST) to evaluate whether changes in pain sensitivity and pain modulation occur as a result of long-term opioid use. Investigators hypothesize that increases in pain sensitivity (i.e., OIH) and maladaptive changes in endogenous pain modulation (i.e., enhanced temporal summation of pain) will occur as a result of long-term opioid use, but that these changes will be observed predominantly among patients with high levels of negative affect and pain-related catastrophizing.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Drug: Oxycodone or morphine sulfate immediate release (MSIR)
    Oxycodone or morphine sulfate immediate release (MSIR)
    Other Name: Oral Opioid Medication
  • Drug: Placebo Treatment
    Lactose (Appearance and Weight-matched placebo capsules)
Study Arms  ICMJE
  • Experimental: Oral Opioid Medication
    The primary study medication will be oxycodone, with morphine sulfate immediate release (MSIR) as a backup in case of side effects
    Intervention: Drug: Oxycodone or morphine sulfate immediate release (MSIR)
  • Placebo Comparator: Placebo Treatment
    Placebo medications will be encapsulated in an opaque blinding capsule to ensure adequate blinding of study medications
    Intervention: Drug: Placebo Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. age 25-65
  2. CLBP lasting for more than 6 months as the primary complaint
  3. typical pain ratings ≥ 4/10 on a visual analogue scale
  4. candidate for oral opioid therapy as assessed at the BWH Pain Management Center
  5. able to speak and understand English.

Exclusion Criteria:

  1. evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures
  2. current (i.e., active) substance use disorder (SUD)
  3. past history of persistent opioid use (i.e., opioid use for more than 6 months) given that this could affect the biological systems of interest in the present study
  4. history of myocardial infarction or other serious cardiovascular condition
  5. current peripheral neuropathy
  6. current pregnancy, or intention to become pregnant during the study
  7. current intrathecal pump.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marise Cornelius 617-732-9463 mcornelius@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02824276
Other Study ID Numbers  ICMJE 2016P000725
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robert Edwards, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Robert Edwards, PhD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP