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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02824276
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : January 28, 2021
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Robert Edwards, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Oxycodone or morphine sulfate immediate release (MSIR) Drug: Placebo Treatment Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
Actual Study Start Date : January 6, 2017
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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
Drug: Oxycodone or morphine sulfate immediate release (MSIR)
Oxycodone or morphine sulfate immediate release (MSIR)
Other Name: Oral Opioid Medication

Placebo Comparator: Placebo Treatment
Placebo medications will be encapsulated in an opaque blinding capsule to ensure adequate blinding of study medications
Drug: Placebo Treatment
Lactose (Appearance and Weight-matched placebo capsules)

Primary Outcome Measures :
  1. Changes in Pain Sensitivity (Quantitative Sensory Testing) [ Time Frame: 6 months ]
    Pain Sensitivity will be assessed by Quantitative Sensory testing

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02824276

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Contact: Marise Cornelius 617-732-9463

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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02467
Contact: Robert Edwards, PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Robert Edwards, PhD Brigham and Women's Hospital
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Responsible Party: Robert Edwards, Associate Professor of Anesthesia, Brigham and Women's Hospital Identifier: NCT02824276    
Other Study ID Numbers: 2016P000725
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents