Development of an Opioid Withdrawal Clinical Outcome Assessment

Development of an Opioid Withdrawal Clinical Outcome Assessment Among Persons With Opioid Use Disorder

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07094672

Enrollment

Registered

2025-07-30

Start date

2026-10-01

Completion date

2028-09-30

Last updated

2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder

Keywords

opioid, fentanyl, withdrawal, naloxone

Brief 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.

Detailed description

Participants with opioid use disorder will complete a two sessions in a within-subject study design to compare their responses to withdrawal questions after experiencing naloxone-precipitated withdrawal and following an overnight observation of spontaneous withdrawal. All participants will complete both sessions and the order of sessions will be randomized. The primary outcome will be cognitive interviews, which will be conducted within 8 hours of each observation period ending to query all possible symptoms associated with the withdrawal experience. Participants will be offered referrals to aftercare prior to study discharge and transitions to treatment programs will be facilitated whenever possible.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cognitive interview	Within 8 hours of completing the withdrawal experience	The experience of withdrawal will be probed qualitatively using cognitive interviews to capture all possible symptoms that opioid withdrawal may elicit in an individual

Countries

United States

Contacts

CONTACTKelly E Dunn, Ph.D., MBA

kelly.dunn@som.umaryland.edu410

Outcome results