DDT COA #000138: Opioid Craving PRO
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Anesthesia, Addiction Medicine, and Pain Medicine (DAAP)
DDT COA Number
DDT COA #000138
Instrument Name
Opioid Craving
Disease/Condition
Opioid Use Disorder (OUD)
Concept of Interest
Changes in opioid craving
Context of Use
Patients with mild to severe OUD
COA Type
PRO
Qualification Stage
Letter of Intent-Accepted
Requestor(s)
Johns Hopkins University School of Medicine
Contact(s)
Cecilia Bergeria
Kelly Dunn
Eric Strain
Date Accepted into CDER’s COA Qualification Program
October 2, 2020
Submission and Regulatory Correspondence History
| Qualification Submission | Date | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
| Letter of Intent | 7/15/20 | FDA Response (Accepted) | 10/2/20 |