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Opioid Analgesic

Opioids for Lower Back Pain

Phase 1
Waitlist Available
Led By Robert Edwards, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
typical pain ratings ≥ 4/10 on a visual analogue scale
CLBP lasting for more than 6 months as the primary complaint
Must not have
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
Evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial is studying chronic low back pain and opioids.

Who is the study for?
This trial is for adults aged 25-65 with chronic low back pain lasting over 6 months and experiencing pain levels of at least 4/10. Participants must be candidates for oral opioid therapy, speak English, and not have a history of long-term opioid use or serious health issues like heart conditions, cognitive impairments, substance use disorders, neuropathy, or pregnancy.
What is being tested?
The study tests the sensory effects of two treatments on chronic low back pain: one group receives Oxycodone or morphine sulfate immediate release (MSIR), while another gets a placebo. The goal is to understand how different people respond to opioids in managing their back pain.
What are the potential side effects?
Opioids like Oxycodone and MSIR can cause drowsiness, constipation, nausea, addiction potential, respiratory depression (slowed breathing), and increased sensitivity to pain with long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My usual pain level is 4 or higher out of 10.
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I have had lower back pain as my main issue for over 6 months.
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My usual pain level is 4 or higher out of 10.
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I am between 25 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have used opioids for more than 6 months in the past.
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I do not have any mental conditions that would stop me from following the study's procedures.
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I have had a heart attack or another serious heart condition.
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I am experiencing numbness, tingling, or pain in my hands or feet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in Pain Sensitivity (Quantitative Sensory Testing)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral Opioid MedicationExperimental Treatment1 Intervention
The primary study medication will be oxycodone, with morphine sulfate immediate release (MSIR) as a backup in case of side effects
Group II: Placebo TreatmentPlacebo Group1 Intervention
Placebo medications will be encapsulated in an opaque blinding capsule to ensure adequate blinding of study medications

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,841,589 Total Patients Enrolled
13 Trials studying Low Back Pain
2,119 Patients Enrolled for Low Back Pain
National Institute on Drug Abuse (NIDA)NIH
2,589 Previous Clinical Trials
3,328,482 Total Patients Enrolled
10 Trials studying Low Back Pain
816 Patients Enrolled for Low Back Pain
Robert Edwards, PhDPrincipal Investigator - Brigham and Women's Hospital
Brigham and Women's Hospital
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Oxycodone or morphine sulfate immediate release (MSIR) (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT02824276 — Phase 1
Low Back Pain Research Study Groups: Oral Opioid Medication, Placebo Treatment
Low Back Pain Clinical Trial 2023: Oxycodone or morphine sulfate immediate release (MSIR) Highlights & Side Effects. Trial Name: NCT02824276 — Phase 1
Oxycodone or morphine sulfate immediate release (MSIR) (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02824276 — Phase 1
Low Back Pain Patient Testimony for trial: Trial Name: NCT02824276 — Phase 1
~4 spots leftby Dec 2025
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