Development of an Opioid Withdrawal Clinical Outcome Assessment

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

30 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Study population

Adults with opioid use disorder located or able to access the Baltimore regional area

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

University of Maryland, Baltimore

Study start

Dec 1, 2026 Estimated

Primary completion

Sep 30, 2027 Estimated

Study completion

Sep 30, 2028 Estimated

First posted

Jul 30, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts