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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05203770
Other study ID # STU00207384
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 31, 2018
Est. completion date June 30, 2024

Study information

Verified date March 2024
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Northwestern University Chicago Illinois
United States Shirley Ryan Ability Lab Chicago Illinois

Sponsors (3)

Lead Sponsor Collaborator
Northwestern University National Institutes of Health (NIH), Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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