Development of an Opioid Withdrawal Clinical Outcome Assessment

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07094672
Status
Not Yet Recruiting

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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jul 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: WIthdrawal assessment_precipitated session
    Assessment of withdrawal following elicitation
  • Arm: Withdrawal assessment_spontaneous
    Assessment of withdrawal during a period of opioid abstinence

Primary Outcome Measure

Cognitive interview [ Time Frame: Within 8 hours of completing the withdrawal experience ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kahlert Institute for Addiction MedicineBaltimoreMaryland21201
Kelly E Dunn, Ph.D., MBA
[email protected]
202-963-1952

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Kahlert Institute for Addiction Medicine· Baltimore, MD

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