Development of an Opioid Withdrawal Clinical Outcome Assessment

University of Maryland Baltimore (UMB)

Status: Begins enrollment in 4 months

Conditions: Opioid Use Disorder

Study type: Observational

Funder types: Other

Identifiers

NCT07094672

HP-00114126

UG3DA062907 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

30 participants in 2 patient groups

WIthdrawal assessment_precipitated session

Description:

Assessment of withdrawal following elicitation

Withdrawal assessment_spontaneous

Description:

Assessment of withdrawal during a period of opioid abstinence