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Opioid

Opioids for Chronic Low Back Pain

Phase 2
Recruiting
Led By Apkar V Apkarian, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights

Study Summary

This trial is designed to see how different treatments affect brain function in people with chronic back pain who are using or misusing opioids.

Eligible Conditions
  • Chronic Low Back Pain
  • Back Pain
  • Chronic Pain
  • Back Injury
  • Opioid Use Disorder
  • Opioid Addiction
  • Drug Abuse
  • Chronic Lower Back Pain

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Differences across drugs in Withdrawal relief assessed by Pain and Craving Index (PCI).
Differences across drugs in pain changes as assessed by Numeric Rating Scale (0-10).
Secondary outcome measures
Differences in pain changes (NRS) across High and Low Misuse groups measured by the Current Opioid Misuse Measure (COMM).
Differences in withdrawal changes (PCI) across High and Low Misuse groups measured by the Current Opioid Misuse Measure (COMM).

Side effects data

From 2019 Phase 4 trial • 1561 Patients • NCT03472469
5%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
MAST MMPR - Escalating Dose Arm
Original MMPR - Descending Dose Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: Chronic Back Pain with Opioid UseExperimental Treatment3 Interventions
Subjects of this arms will be on a previously prescribed, short term acting opioid. Previous to each of the three imaging visits, subjects will be instructed to withhold from taking their regular morning opioid dose. Subjects will be randomized into a group that determines the sequence of which they will receive the study drugs. The three sequences are as follows: treatment dose #1: 25mg carbidopa/ 100mg levodopa + 500mg naproxen, treatment dose #2: subjects prescribed, short acting opioid; treatment dose #1: placebo, treatment dose #2: subjects prescribed, short acting opioid; or treatment #1: subjects prescribed, short acting opioid, treatment dose #2: placebo.
Group II: Chronic Back Pain with Opioid Misuse DisorderExperimental Treatment3 Interventions
Subjects of this arms will be on a previously prescribed, short term acting opioid. Previous to each of the three imaging visits, subjects will be instructed to withhold from taking their regular morning opioid dose. Subjects will be randomized into a group that determines the sequence of which they will receive the study drugs. The three sequences are as follows: treatment dose #1: 25mg carbidopa/ 100mg levodopa + 500mg naproxen, treatment dose #2: subjects prescribed, short acting opioid; treatment dose #1: placebo, treatment dose #2: subjects prescribed, short acting opioid; or treatment #1: subjects prescribed, short acting opioid, treatment dose #2: placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen 500 Mg
2018
Completed Phase 4
~200
Opioids
2018
Completed Phase 4
~1950

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,151 Total Patients Enrolled
Shirley Ryan AbilityLabOTHER
192 Previous Clinical Trials
14,805 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,499 Total Patients Enrolled

Frequently Asked Questions

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

Could you please detail the risks and benefits of opioid use?

"Since this is a Phase 2 trial, there is only some data supporting the safety of opioids. A score of 2 was given by our team at Power."

Answered by AI

Are there any spaces available for new participants in this trial?

"The study, which is currently enrolling patients, was first posted on the website clinicaltrials.gov on 1/1/2021. The most recent update to the study's information was made on 7/13/2022."

Answered by AI

How many people can join this clinical trial at the most?

"That is accurate. The listing on clinicaltrials.gov says that this study is still looking for test subjects. Eighty individuals are required for the trial, which is being conducted at a single location."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Pennsylvania
Other
Michigan
How old are they?
65+
18 - 65
What site did they apply to?
Northwestern University Feinberg School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I need help with my addiction and might as well get paid to correct it.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure
Apkar Apkarian 2021. "Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05463367.
~19 spots leftby Apr 2025
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