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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kahlert Institute for Addiction Medicine

Baltimore, Maryland, 21201, United States

Location contact

Kelly E Dunn, Ph.D., MBA

CONTACT

[email protected]

202-963-1952

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Cognitive interview

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly E Dunn, Ph.D., MBA

CONTACT

[email protected]

410 ext. 202-963-1952

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Jul 30, 2025
Registry last updated: Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting