MedTrace Logo

Development of an Opioid Withdrawal Clinical Outcome Assessment

NCT07094672 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-07-30

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07094672 on ClinicalTrials.gov