drugset / Trial / NCT05463367
Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure
Phase 2
Active not recruiting
60 enrolled
Northwestern University
National Institutes of Health (NIH) · collabShirley Ryan AbilityLab · collab
RandomizedCrossoverDouble-blindTreatment
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.
Timeline
- Start
- 2021-01-01
- Primary completion
- 2025-06-01
- Completion
- 2025-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Codeine | Small molecule | — | — |
| Subject | Morphine | Other / unclassified | — | — |
| Subject | Naproxen | Small molecule | 500 mg | — |
| Subject | Oxycodone | Other / unclassified | — | — |
| Subject | Oxymorphone | Small molecule | — | — |
| Subject | Tramadol | Other / unclassified | — | — |
| Subject | carbidopa-levodopa | Unknown | 25 mg | Oral |
| Subject | carbidopa-levodopa | Unknown | 100 mg | Oral |
| Subject | hydrocodone/acetaminophen | Unknown | — | — |
| Subject | oxycodone/acetaminophen | Unknown | — | — |