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ACTIVE NOT RECRUITING
NCT05463367
PHASE2

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

Sponsor: Northwestern University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-01-01

Completion Date

2025-06-01

Last Updated

2024-11-27

Healthy Volunteers

No

Interventions

DRUG

Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet

Subjects will receive a single dose of carbidopa/levodopa, when applicable.This will be double-blinded, as neither participants nor study staff will know what medication the participant is receiving.

DRUG

Naproxen 500 Mg

Subjects will receive a single dose of naproxen 500mg alongside carbidopa/levodopa, when applicable.This will be double-blinded, as neither participants nor study staff will know what medication the participant is receiving.

DRUG

Opioids

Subjects will be pre-screened in regards to their opioid medication. They will receive a single dose of their opioid dose, when appropriate. This will be double-blinded, as neither participants nor study staff will know what medication the participant is receiving.

Locations (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States