Your session is about to expire
← Back to Search
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have used opioids for more than 6 months in the past.
Select...
I do not have any mental conditions that would stop me from following the study's procedures.
Select...
I have had a heart attack or another serious heart condition.
Select...
I am experiencing numbness, tingling, or pain in my hands or feet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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
1,664 Previous Clinical Trials
11,834,951 Total Patients Enrolled
13 Trials studying Low Back Pain
2,119 Patients Enrolled for Low Back Pain
National Institute on Drug Abuse (NIDA)NIH
2,577 Previous Clinical Trials
3,286,804 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have a pump implanted in your body for delivering medication into the spinal canal.My usual pain level is 4 or higher out of 10.I have had lower back pain as my main issue for over 6 months.You are currently struggling with drug or alcohol addiction.I have used opioids for more than 6 months in the past.I do not have any mental conditions that would stop me from following the study's procedures.I have had a heart attack or another serious heart condition.I am experiencing numbness, tingling, or pain in my hands or feet.My usual pain level is 4 or higher out of 10.I am considered a candidate for oral opioid pain medication.I am between 25 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Opioid Medication
- Group 2: Placebo Treatment
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Low Back Pain Patient Testimony for trial: Trial Name: NCT02824276 — Phase 1
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger