Development of an Opioid Withdrawal Clinical Outcome Assessment

Withdrawal management strategies are currently the most utilized and ubiquitous intervention for opioid use disorder in the US, yet existing measures of opioid withdrawal lack Food and Drug Administration (FDA) qualification. This project will develop and validate a clinical outcome assessment (COA) for opioid withdrawal,essential for standardizing withdrawal mitigation strategies and establishing best practices. In line with the FDA's drug development tool qualification guidelines, our methodological process will involve conducting focus groups with persons with lived experience of opioid withdrawal for concept elicitation, refining these concepts through cognitive interviews, and conducting construct and longitudinal validations of the new assessment in laboratory settings and across diverse treatment contexts.

NCT Number	NCT07094672
Lead Sponsor	University of Maryland, Baltimore Collaborators: National Institute on Drug Abuse (NIDA)
Conditions	Opioid Use Disorder
Enrollment	30 participants
Start Date	2026-10-01
Primary Completion	2027-09-30 (estimated)
Study Completion	2028-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-14