Adaptations of the Brain in Chronic Pain With Opioid Exposure I

NCT05203770 | Active Not Recruiting DMC

• 1 other identifier: STU00207384
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Back Pain; Opioid Use

Keywords

Opioids; Opioid Misuse Disorder; Brain Adaptations; biomarkers

Outcome Measures

Primary Outcomes (2)

• To determine effects of opioid exposure on human brain anatomy and function in CBP using resting-state functional magnetic resonance (fMRI).

  We will test the impact of opioid use on brain anatomy and function. For this, all participants will undergo a resting-state functional magnetic resonance (fMRI) exam. Measures of brain anatomy and brain connectivity will be acquired and compared between the observational groups (CBP+O and CBP+mOUD, relative to CBP-O and healthy control). We seek to establish risk factors and brain biomarkers for OUD and relate brain adaptations to exposure to both opioids and chronic pain.

  1-2 years

• To determine cognition, emotion, and motor abilities with opioid exposure in CBP, and to identify associated human brain maladptions.

  We will test the impact of opioid use on abilities in CBP+O and CBP+mOUD, relative to CBP-O and healthy controls. For this participants will respond to questionnaires related to their thoughts and feelings.

  1-2 years

Study Arms (4)

CBP+mOUD

Chronic Back pain participants taking opioids and classified in the opioid misuse disorder group

CBP+O

Chronic Back pain participants taking opioids and without opioid misuse disorder group

CBP-O

Chronic Back pain participants not taking opioids

Healthy Controls

Healthy control without pain or taking opioids.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects must be 18 years or older. Male and Female No racial/ethnic restrictions General health status: generally good health

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Northwestern University: lead
• Shirley Ryan AbilityLab: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Shirley Ryan Ability Lab

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, urine

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: January 24, 2022
• Study Start: October 31, 2018
• Primary Completion: February 23, 2023
• Study Completion: June 30, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

US (2)