Development of an Opioid Withdrawal Clinical Outcome Assessment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development of an Opioid Withdrawal Clinical Outcome Assessment Among Persons With Opioid Use Disorder
Overview
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
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.
Primary outcome measures
- Cognitive interview [Time frame: Within 8 hours of completing the withdrawal experience]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
United States · 1 center
- Kahlert Institute for Addiction Medicine — Baltimore
Identifiers
NCT: NCT07094672 · HP-00114126 · UG3DA062907