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.

Inclusion Criteria: * Past year opioid use disorder, determined by (a) enrollment in current treatment for opioid use disorder and/or (b) an opioid-positive saliva test. * Fluent in English * Has experience with opioid withdrawal at least once in the past 30 days Exclusion Criteria: * Unable to provide informed consent due to cognitive impairment * Being pregnant or breastfeeding * History of psychosis or mania as determined by the MINI * Exhibiting suicidal behavior in the past 30 days as determined by the C-SSRS * Circumstances that could interfere with study participation * Previously participated in affiliated Focus Group study