Opioids for Back Injuries

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Northwestern University Feinberg School of Medicine, Chicago, IL
Back Injuries+12 More
Opioids - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is designed to track brain functional changes in individuals with i) chronic back pain + opioid use (CBP+O) and individuals with ii) chronic back pain + opioid misuse disorder (CBP+mOUD) following a brief drug delay and re-exposure manipulation. Re-exposure could be placebo, the participant's own opioid dose, or a dopaminergic treatment (DA+NSAID). The participants will be also evaluated for changes in cognition, emotion, and motor abilities with opioid delay and re-exposure to placebo, opioid, or DA+NSAID.

Eligible Conditions

  • Back Injuries
  • Opioids Use
  • Opioid Use Disorder (OUD)
  • Back
  • Back Pain
  • Pain
  • Chronic Lower Back Pain (CLBP)
  • Chronic Pain
  • Opioid Dependence
  • Narcotics

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Back Injuries

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 3 weeks

3 weeks
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).
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).

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Back Injuries

Trial Design

2 Treatment Groups

Chronic Back Pain with Opioid Use
1 of 2
Chronic Back Pain with Opioid Misuse Disorder
1 of 2
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Opioids · No Placebo Group · Phase 2

Chronic Back Pain with Opioid UseExperimental Group · 3 Interventions: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet, Naproxen 500 Mg, Opioids · Intervention Types: Drug, Drug, Drug
Chronic Back Pain with Opioid Misuse DisorderExperimental Group · 3 Interventions: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet, Naproxen 500 Mg, Opioids · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen 500 Mg
2018
N/A
~70
Opioids
2018
Completed Phase 4
~1860

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 weeks
Closest Location: Northwestern University Feinberg School of Medicine · Chicago, IL
Photo of Chicago 1Photo of Chicago 2Photo of Chicago 3
2011First Recorded Clinical Trial
1 TrialsResearching Back Injuries
144 CompletedClinical Trials

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,421 Previous Clinical Trials
717,297 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,390 Previous Clinical Trials
24,521,477 Total Patients Enrolled
Shirley Ryan AbilityLabOTHER
167 Previous Clinical Trials
13,084 Total Patients Enrolled
Apkar V Apkarian, PhDPrincipal InvestigatorNorthwestern University Feinberg School of Medicine
3 Previous Clinical Trials
231 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had low back pain for a minimum of 6 months daily (prior to screening).
You must be able to read and understand instructions as well as questionnaires.
You must sign an informed consent document after a complete explanation of the study documenting that you understand the purpose of the study, procedures to be undertaken, possible benefits and potential risks, and are willing to participate.
You must be willing to complete daily smartphone/computer eDiary ratings.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.