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Opioid

Treatments for Chronic Back Pain and Opioid Use Disorder

Phase 2

Waitlist Available

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

No Placebo-Only Group

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.

Who is the study for?

This trial is for adults over 18 with chronic low back pain who have been on short-acting opioid therapy for at least 3 months. Participants must be in stable health, able to read and speak English, and willing to use a daily eDiary. Exclusions include diabetes, long-acting opioids or high doses of opioids (>50mg/day), uncontrolled hypertension, lactose intolerance, certain implants, unstable antidepressant use, other chronic pain/neurological conditions, significant medical diseases like heart failure or renal insufficiency.

What is being tested?

The study observes brain function changes in people with chronic back pain using opioids regularly (CBP+O) and those misusing them (CBP+mOUD). It involves a drug delay followed by re-exposure to either placebo; the participant's usual opioid dose; or dopaminergic treatment combined with NSAID. The impact on cognition, emotion, and motor skills will also be assessed.

What are the potential side effects?

Potential side effects may include typical reactions to Carbidopa-Levodopa such as nausea or dizziness and Naproxen-related issues like stomach upset or headache. Opioids can cause constipation, drowsiness or mood swings. Side effects vary based on individual response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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).

Whole-cortex multi-receptor related activity

Side effects data

From 2019 Phase 4 trial • 1561 Patients • NCT03472469

Death

100%

80%

60%

40%

20%

Study treatment Arm

MAST MMPR - Escalating Dose Arm

Original MMPR - Descending Dose Arm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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: 1. treatment dose #1: 25mg carbidopa/ 100mg levodopa + 500mg naproxen, treatment dose #2: subjects prescribed, short acting opioid; 2. treatment dose #1: placebo, treatment dose #2: subjects prescribed, short acting opioid; or 3. treatment #1: subjects prescribed, short acting opioid, treatment dose #2: placebo.

Group II: Chronic Back Pain with Opioid Misuse DisorderExperimental Treatment3 Interventions

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