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

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.

Conditions

• Opioid Use
• Opioid Dependence
• Opioid-use Disorder
• Narcotic Use
• Back Pain
• Back Injuries
• Chronic Pain
• Chronic Low-back Pain
• Pain, Chronic
• Pain;Back Low;Chronic
• Pain, Back

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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• Northwestern University

  lead OTHER

Principal Investigators

• Apkar V Apkarian, PhD · Northwestern University Feinberg School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2025-06-01

Completion

2025-06-01

FDA Drug

Yes

Countries

• United States

Study Locations