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Search / Trial NCT05027919

Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Aug 24, 2021

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking to understand how different people experience withdrawal symptoms when they stop using opioids, especially those with opioid use disorder (OUD). The study will involve participants who are undergoing a medically supervised reduction of their opioid medication. By examining these individual differences, researchers hope to find ways to make the process of tapering off opioids easier and more effective for everyone.

To participate in this study, individuals need to be between 18 and 65 years old and must have a positive urine test for opioids, which indicates they currently use these medications. It's important that they are physically dependent on opioids and are interested in tapering off. However, individuals who are pregnant, breastfeeding, or have certain medical conditions that require immediate treatment will not be eligible to join. Participants can expect to share their experiences throughout the tapering process, contributing valuable information that could help improve care for others in similar situations.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 18 years - 65 year old
  • Opioid-positive urine sample
  • Current opioid use disorder with evidence of physical dependence
  • Interest in undergoing opioid taper
  • Exclusion Criteria:
  • Evidence of physical dependence on alcohol or benzodiazepines that requires medical intervention
  • Being pregnant or breastfeeding
  • Enrolled in methadone or buprenorphine maintenance treatment
  • Clinically significant hypotension (\<90/60mmHg) or bradycardia (\<45bpm)
  • History of myocardial infarction
  • Subjects who are positive for hepatitis B surface antigen and/or hepatitis C antibody with liver function tests outside the normal range (persons with a positive hepatitis C antibody and normal liver functions tests are NOT excluded from the study)
  • Significant mental health or physical disorder, or life circumstances, that is expected to interfere with study participation

About University Of Maryland, Baltimore

The University of Maryland, Baltimore (UMB) is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, UMB leverages its extensive resources and expertise across various disciplines, including medicine, pharmacy, nursing, and social work, to contribute to groundbreaking discoveries and improve patient outcomes. Committed to ethical research practices and collaboration, UMB fosters an environment that promotes the translation of scientific knowledge into real-world applications, ultimately enhancing the well-being of diverse populations.

Locations

Baltimore, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Kelly E Dunn, Ph.D, M.B.A.

Principal Investigator

Johns Hopkins University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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