Treatments for Chronic Back Pain and Opioid Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the brain changes when individuals with chronic back pain who regularly use or misuse opioids experience a temporary stop and restart of their medication. Participants may receive a placebo (inactive substance), their usual opioid, or a combination of dopamine-related treatment (Carbidopa-Levodopa) and an NSAID (a common pain reliever, such as Naproxen). The study examines the effects on thinking, emotions, and movements. Individuals with low back pain for at least six months who regularly use short-acting opioids may be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires participants to be on regular short-acting opioid therapy for at least 3 months before joining. You should discuss your current medications with the trial team to see if any changes are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both treatments in this trial—carbidopa-levodopa combined with naproxen and opioids—have some safety information available.
Carbidopa-levodopa has been safely used in conditions like Parkinson's disease, helping with movement problems and generally being well-tolerated. However, discussing any possible side effects with a doctor is important.
Naproxen, a type of pain reliever, is generally safe when used correctly. It reduces pain and swelling, which benefits back pain. However, excessive use can cause stomach issues, such as pain or bleeding.
Opioids relieve pain but carry more serious risks if used long-term or incorrectly. Side effects may include nausea, dizziness, or more severe problems. The safety of long-term opioid use is still under study.
Discuss the risks and benefits with a healthcare provider before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for chronic back pain and opioid use disorder because they combine traditional opioids with new regimens that include carbidopa/levodopa and naproxen. Unlike standard treatments that rely solely on opioids, this approach aims to reduce opioid dependency by offering alternative pain relief through a combination of medications. Carbidopa and levodopa are typically used for Parkinson's disease but, in this context, might help manage pain differently, while naproxen provides anti-inflammatory benefits. This mix has the potential to offer effective pain management with reduced opioid use, a promising development for patients struggling with both chronic pain and opioid misuse.
What evidence suggests that this trial's treatments could be effective for chronic back pain and opioid use disorder?
Research has shown that opioids produce mixed results in managing chronic back pain. Although doctors often prescribe opioids, they might not relieve pain or improve quality of life more effectively than other treatments. In this trial, some participants will receive a combination of carbidopa-levodopa and naproxen, which previous studies have shown to reduce pain. This suggests that using carbidopa-levodopa and naproxen together could serve as a helpful alternative for treating chronic back pain.16789
Who Is on the Research Team?
Apkar Apkarian, PhD
Principal Investigator
Northwestern University Feinberg School of Medicine
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo three imaging visits with different drug interventions, including opioids, carbidopa/levodopa, and placebo, with brain MRI scans and cognitive assessments.
Follow-up
Participants are monitored for changes in pain and craving using the Pain and Craving Index (PCI) and other assessments.
What Are the Treatments Tested in This Trial?
Interventions
- Carbidopa-Levodopa
- Naproxen
- Opioids
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
Shirley Ryan AbilityLab
Collaborator
National Institutes of Health (NIH)
Collaborator
Published Research Related to This Trial
Citations
Effect of L-dopa In Subacute Back Pain Population
This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in individuals with sub-acute back pain (SBP) is associated with changes in ...
Record History | ver. 1: 2022-07-13 | NCT05463367
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 ...
Opioids for low back pain - PMC - PubMed Central - NIH
People taking opioids may have had worse initial pain, but the drug did not achieve pain relief or quality of life comparable even to others ...
Multicenter controlled study of Sinemet CR vs ...
According to both physician and patient global ratings, patients showed significant improvements with Sinemet CR compared to treatment with standard Sinemet.
5.
effectivehealthcare.ahrq.gov
effectivehealthcare.ahrq.gov/sites/default/files/related_files/opioids-chronic-pain-surveillance-report-1-final.pdfSystematic Review on Opioid Treatments for Chronic Pain
One new, small (n=19) RCT evaluated buprenorphine/naloxone versus methadone for treatment of opioid use disorder related to prescription opioids in patients ...
Transition From Acute to Chronic Back Pain : Effect of L ...
This is a 6-month double-blinded, randomized, placebo-controlled clinical trial of pharmacological treatment for acute/subacute back pain (carbidopa/levodopa ...
A 12-month, dose-level blinded safety and efficacy study of ...
At 12 months, 73.0% of patients on 84 mg achieved an ON state within 60 min. Total daily OFF time was reduced by 0.55 h (month 1) and 0.88 h (month 12) for the ...
Opioids and Chronic Pain: An Analytic Review of the ...
We conducted an analytic review of the clinical scientific literature bearing on the use of opioids for treatment of chronic non-cancer pain.
IPX203 vs Immediate-Release Carbidopa-Levodopa for ...
The results of this study suggest that IPX203 vs immediate-release carbidopa-levodopa may be useful in patients with Parkinson disease and motor fluctuations.
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