Adaptations of the Brain in Chronic Pain With Opioid Exposure I
Unknown statusNCT05203770
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 investigates brain reorganization and behavioral responses in chronic pain with opioid exposure in Chronic Back Pain (CBP).
Study details
- Official title
- Adaptations of the Brain in Chronic Pain With Opioid Exposure I
- Conditions
- Sponsor
- Northwestern University
- Collaborators
- Shirley Ryan AbilityLab; National Institutes of Health (NIH)
- Start date
- 2018-10-31
- Primary completion
- 2023-02-23
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
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 have a Visual Analog Scale (VAS) pain score ≥ 40 mm (of 100 mm maximum) at the baseline scanning visit (for which 0mm = no pain, and 100 mm = worst pain imaginable); * 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 1-2 week period prior to the brain scanning visit; * Must be willing to complete daily smartphone/computer app ratings; * Must be on regular opioid or NSAID therapy for at least 3 months prior to randomization (for opioid and non-opioid treatment groups, respectively), which will be up to the clinical investigator's decision. Exclusion Criteria: * Low back pain associated with any systemic signs or symptoms, e.g., fever, chills; * Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, * fibromyalgia, history of tumor in the back; * Other comorbid chronic pain or neurological conditions; * Involvement in litigation regarding their back pain or having a disability claim or receiving workman's compensation or seeking either as a result of back pain; * Diagnosis of current major depression or psychiatric disorder requiring treatment, or such a diagnosis in the previous 6 months; * Beck Depression Inventory II score of \>28; * 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 medical disease such as diabetes, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy; * Uncontrolled hypertension; * Renal insufficiency; * Current use of recreational drugs or history of alcohol or drug abuse; * Any change in medication for back pain in the last 30 days; * High dose opioid prophylaxis, as defined as \> 50mg morphine equivalent/day; * Any medical condit…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05203770