Development of an Opioid Withdrawal Clinical Outcome Assessment

NCT ID: NCT07094672

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-07-01

Study Completion Date

2028-06-30

Brief Summary

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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

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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.

Conditions

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Opioid Use Disorder

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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WIthdrawal assessment_precipitated session

Assessment of withdrawal following elicitation

No interventions assigned to this group

Withdrawal assessment_spontaneous

Assessment of withdrawal during a period of opioid abstinence

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Kelly Dunn

Director, Kahlert Institute for Addiction Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kahlert Institute for Addiction Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

Central Contacts

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Kelly E Dunn, Ph.D., MBA

Role: CONTACT

410 ext. 202-963-1952

Facility Contacts

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Kelly E Dunn, Ph.D., MBA

Role: primary

202-963-1952

Other Identifiers

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UG3DA062907

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00114126

Identifier Type: -

Identifier Source: org_study_id

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