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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
I have had lower back pain as my main issue for over 6 months.
Select...
My usual pain level is 4 or higher out of 10.
Select...
I am between 25 and 65 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Pain Sensitivity (Quantitative Sensory Testing)

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
1,608 Previous Clinical Trials
11,469,842 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,558 Total Patients Enrolled
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
Lower Back Pain Research Study Groups: Oral Opioid Medication, Placebo Treatment
Lower 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
Lower Back Pain Patient Testimony for trial: Trial Name: NCT02824276 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 60 or older eligible to join this investigation?

"This particular medical experiment has the following eligibility criteria: 25 to 65 years old. Perusing clinicaltrials.gov, there are 30 trials for minors and 313 studies on seniors."

Answered by AI

How many vacancies remain for participants in this experiment?

"Affirmative. Clinicaltrials.gov contains data illustrating that this medical trial is currently enrolling individuals, which commenced on January 6th 2017 and was most recently updated August 30th 2022. The research requires 100 people from a single site to participate in the study."

Answered by AI

What is the current participation rate for this medical research?

"Affirmative, clinicaltrials.gov has recorded that this medical trial is actively looking for volunteers. The study was initially unveiled on June 1st 2017 and was last revised on August 30th 2022; presently they need to find 100 participants at one location."

Answered by AI

To what degree are Oxycodone or morphine sulfate immediate release (MSIR) safe for patients?

"The safety of Oxycodone or morphine sulfate immediate release (MSIR) is initially judged to be a 1 on the scale from 1-3 due to this being a Phase 1 study, indicating that there is limited data in regards to efficacy and safety."

Answered by AI

Could you provide details of prior investigations into Oxycodone or MSIR?

"At present, 76 studies concerning Oxycodone or Morphine Sulfate Immediate Release (MSIR) are operational with 20 trials in their terminal stage. Most of these investigations are centered around Boston, Massachusetts; however there exist 156 other locations running related experiments."

Answered by AI

Is there a way to become involved in this medical research?

"Eligibility for this medical trial necessitates that the patient has low back pain and is between 25-65 years of age. This study will be taking in a maximum of 100 participants."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
Florida
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I am looking for some to relief my back.
PatientReceived 2+ prior treatments
~4 spots leftby Apr 2025