Development of an Opioid Withdrawal Clinical Outcome Assessment

NCT07094672 | Not Yet Recruiting DMC

• 2 other identifiers: HP-00114126UG3DA062907
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

opioid; fentanyl; withdrawal; naloxone

Outcome Measures

Primary Outcomes (1)

• Cognitive interview

  The experience of withdrawal will be probed qualitatively using cognitive interviews to capture all possible symptoms that opioid withdrawal may elicit in an individual

  Within 8 hours of completing the withdrawal experience

Study Arms (2)

WIthdrawal assessment_precipitated session

Assessment of withdrawal following elicitation

Withdrawal assessment_spontaneous

Assessment of withdrawal during a period of opioid abstinence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Kahlert Institute for Addiction Medicine

Baltimore, Maryland, 21201, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Kelly E Dunn, Ph.D., MBA

CONTACT

410; kelly.dunn@som.umaryland.edu

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Kahlert Institute for Addiction Medicine

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)