Adaptations of the Brain in Chronic Pain With Opioid Exposure I

  • STATUS
    Recruiting
  • End date
    Apr 26, 2023
  • participants needed
    250
  • sponsor
    Northwestern University
Updated on 22 March 2022
Accepts healthy volunteers

Summary

This study investigates brain reorganization and behavioral responses in chronic pain with opioid exposure in Chronic Back Pain (CBP).

Description

Chronic back pain (CBP) is the most prevalent chronic pain condition in the US. Opiates are commonly prescribed to treat CBP; as such, these patients are a primary contributor to the current opioid epidemic. This study will assess the impact of opioid use on brain anatomy and function in those subjects taking opioids without opioid misuse disorder, as well as those subjects with opioid misuse disorder, relative to those with CBP and are not taking opioids and healthy controls. This is an observational study, that seeks to establish risk factors and brain biomarkers for opioid misuse disorder and relate brain adaptations to exposure to both opioids and chronic pain. This study also seeks to determine the impact of opioid use on cognitive, emotional, and motor abilities.

Details
Condition Chronic Back Pain, Opioid Use
Clinical Study IdentifierNCT05203770
SponsorNorthwestern University
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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 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
Diabetes (type 1 or type 2)
Lactose intolerance
Allergic reaction to naproxen or any NSAID
Any untoward reaction to l-dopa or carbidopa
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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