Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Anesthesia, Addiction Medicine, and Pain Medicine (DAAP)

DDT COA Number
DDT COA #000110

Instrument Name
WHO Risk Drinking Levels of Alcohol Consumption

Disease/Condition
Alcohol use disorder (AUD)

Concept of Interest
WHO 2-level risk drinking reduction

Context of Use
Patients diagnosed with an AUD

COA Type
PRO

Qualification Stage
Letter of Intent- Accepted 

Requestor(s)
The Alcohol Clinical Trials Initiative (Active)

Contact(s)
Raye Litten

Date Accepted into CDER’s COA Qualification Program
April 23, 2019

Submission and Regulatory Correspondence History