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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02824276
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
100
Enrollment
1
Location
2
Arms
56.8
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 6, 2017
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

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 Names:
  • 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)

    Outcome Measures

    Primary Outcome Measures

    1. Changes in Pain Sensitivity (Quantitative Sensory Testing) [6 months]

      Pain Sensitivity will be assessed by Quantitative Sensory testing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 65 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02467

    Sponsors and Collaborators

    • Brigham and Women's Hospital
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Principal Investigator: Robert Edwards, PhD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Edwards, Associate Professor of Anesthesia, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT02824276
    Other Study ID Numbers:
    • 2016P000725
    First Posted:
    Jul 6, 2016
    Last Update Posted:
    Jan 28, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Back Pain
    Low Back Pain
    Morphine
    Oxycodone

    Study Results

    No Results Posted as of Jan 28, 2021