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Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure

Active, not recruitingPhase 2NCT05463367
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure
Interventions
  • Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet
  • Drug: Naproxen 500 Mg
  • Drug: Opioids
Sponsor
Northwestern University
Collaborators
Shirley Ryan AbilityLab; National Institutes of Health (NIH)
Start date
2021-01-01
Primary completion
2025-06-01
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * History of low back pain for a minimum of 6 months daily (prior to screening), meeting the Quebec Task Force Classification System symptom categories I-III; * Male or female, age equal or greater than 18 years, with no racial/ethnic restrictions; * Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires; * Must be in generally stable health; * Must sign an informed consent document after a complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits and potential risks, and are willing to participate; * Must have, on average ≥ 4/10 units of pain intensity over the course of a 1-4 week period prior to the brain scanning visit; * Must be willing to complete daily smartphone/computer eDiary ratings; * Must be on regular opioid therapy or for at least 3 months prior to randomization which will be up to the clinical investigator's decision * Must be on a short acting opioid therapy (anticipated duration of action \< 6 hours) Exclusion Criteria: * Low back pain associated with any systemic signs or symptoms, e.g., fever, chills; * Other comorbid chronic pain or neurological conditions; * Use of therapeutic doses of antidepressant medications at unstable doses (i.e., tricyclic depressants, SSRIs, SNRIs; low doses used for sleep may be allowed); * Significant other unstable medical disease such as diabetes, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy; * Uncontrolled hypertension; * Renal insufficiency;(correlated creatinine clearance \< 40mL/min or serum creatinine ≥2) * Daily use of high doses of opioids,, as defined as \> 50mg morphine equivalent/day; * Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk; * In the judgment of the investigator, unable or unwilling to follow protocol and instructions; * Evidence of poor treatment compliance, in the judgment of the investigator; * Intra-axial implants (e.g. spinal cord stimulators or pumps); * All exclusion criteria for MR safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia; * Pregnancy, or inability to use an effective form of contraception in women of child-bearing age; * An established diagnosis of diabetes (type 1 or type 2) * Lactose…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05463367