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

Primary Purpose

Low Back Pain

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxycodone or morphine sulfate immediate release (MSIR)
Placebo Treatment
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral Opioid Medication

Placebo Treatment

Arm Description

The primary study medication will be oxycodone, with morphine sulfate immediate release (MSIR) as a backup in case of side effects

Placebo medications will be encapsulated in an opaque blinding capsule to ensure adequate blinding of study medications

Outcomes

Primary Outcome Measures

Changes in Pain Sensitivity (Quantitative Sensory Testing)
Pain Sensitivity will be assessed by Quantitative Sensory testing

Secondary Outcome Measures

Full Information

First Posted
June 28, 2016
Last Updated
May 30, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02824276
Brief Title
Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
Official Title
Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 6, 2017 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Opioid Medication
Arm Type
Experimental
Arm Description
The primary study medication will be oxycodone, with morphine sulfate immediate release (MSIR) as a backup in case of side effects
Arm Title
Placebo Treatment
Arm Type
Placebo Comparator
Arm Description
Placebo medications will be encapsulated in an opaque blinding capsule to ensure adequate blinding of study medications
Intervention Type
Drug
Intervention Name(s)
Oxycodone or morphine sulfate immediate release (MSIR)
Other Intervention Name(s)
Oral Opioid Medication
Intervention Description
Oxycodone or morphine sulfate immediate release (MSIR)
Intervention Type
Drug
Intervention Name(s)
Placebo Treatment
Intervention Description
Lactose (Appearance and Weight-matched placebo capsules)
Primary Outcome Measure Information:
Title
Changes in Pain Sensitivity (Quantitative Sensory Testing)
Description
Pain Sensitivity will be assessed by Quantitative Sensory testing
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 25-65 CLBP lasting for more than 6 months as the primary complaint typical pain ratings ≥ 4/10 on a visual analogue scale candidate for oral opioid therapy as assessed at the BWH Pain Management Center able to speak and understand English. Exclusion Criteria: evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures current (i.e., active) substance use disorder (SUD) 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 history of myocardial infarction or other serious cardiovascular condition current peripheral neuropathy current pregnancy, or intention to become pregnant during the study current intrathecal pump.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Edwards, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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