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NCT07094672 · ClinicalTrials.gov registry record
Development of an Opioid Withdrawal Clinical Outcome Assessment
A clinical trial, sponsored by University of Maryland, Baltimore.
- Not yet
- Registry status
- 30
- Enrollment target
NCT07094672: Clinical Trial study, sponsored by University of Maryland, Baltimore.
NCT07094672 is a clinical trial that has not yet begun recruiting, run by University of Maryland, Baltimore. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07094672 has not yet begun recruiting, sponsored by University of Maryland, Baltimore.
- NOT YET RECRUITING
- Registry status
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
The experience of withdrawal will be probed qualitatively using cognitive interviews to capture all possible symptoms that opioid withdrawal may elicit in an individual
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2028-06-30 |
What is known before NCT07094672 opens enrollment
NCT07094672 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT07094672 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07094672 about?
NCT07094672 is a clinical study titled "Development of an Opioid Withdrawal Clinical Outcome Assessment". 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)...
What is the current status of trial NCT07094672?
This trial is currently not yet recruiting. The enrollment target is 30 participants. The study started on 2026-07-01. Estimated completion is 2028-06-30.
Who is sponsoring clinical trial NCT07094672?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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