Development of an Opioid Withdrawal Clinical Outcome Assessment (NCT07094672)
Development of an Opioid Withdrawal Clinical Outcome Assessment Among Persons With Opioid Use Disorder
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Kahlert Institute for Addiction Medicine — Baltimore, Maryland
Age range: 18 Years
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Kahlert Institute for Addiction Medicine — Baltimore, Maryland
📞 Contact the Study Coordinator
Phone: (202) 963-1952
Email: kelly.dunn@som.umaryland.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Opioid Use Disorder
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- The Emergency Department Longitudinal Integrated Care — Seattle, Washington
- Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT — La Jolla, California
- Extended-release Buprenorphine as a Novel Low-dose Induction Strategy — Boston, Massachusetts
- Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial — Ann Arbor, Michigan
- Telemedicine XR-B for Individuals in Jail — Cumberland, Maryland
Explore by condition: All Opioid Use Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.