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Search / Trial NCT06527599

Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention

Launched by UNIVERSITY OF WISCONSIN, MADISON · Jul 25, 2024

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, called "Screening in Trauma for Opioid Misuse Prevention," is exploring a new approach to help people who have been hospitalized for serious injuries reduce their chances of misusing opioids, which are strong pain medications. The goal is to see how well this intervention works from both the perspective of the healthcare providers and the patients. They hope to learn whether it is possible to provide this type of help and if patients find it acceptable. About 107 people will take part in the study, which will last for up to six months.

To be eligible for this trial, participants must be at least 18 years old, speak and read English fluently, and have been admitted to the hospital for a serious injury that requires immediate medical attention. They should also have received a specific amount of pain medication or have a prescription for opioids when they leave the hospital. However, some individuals, such as those with certain health conditions, those who cannot give consent, or those currently involved in drug-related legal issues, may not be able to participate. If someone joins the study, they can expect to receive support aimed at preventing opioid misuse while they recover from their injury.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Able to speak, read, and write fluently in English.
  • Admission to site hospital for a traumatic injury at time of screening. A traumatic injury is defined as a physical injury with sudden onset requiring immediate medical attention.
  • Injury severity score of 9 or greater.
  • * Meets at least one of the following descriptions below:
  • Received 40 mg morphine milligram equivalent (MME) within 48 hours of pre-screening; or
  • Discharged with a prescription for an opioid medication.
  • Expected to be in control of their own medications at the time of discharge from the controlled environment of hospital or short-term rehabilitation.
  • Exclusion Criteria:
  • Inability to provide written consent for any reason.
  • Current self-reported diagnosis of cancer with life expectancy less than 12 months at time of screening.
  • Current prescription for opioid use disorder (e.g., suboxone, buprenorphine, methadone, naltrexone), with a current diagnosis of opioid use disorder (OUD) (mild or greater) not in remission.
  • History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, or vascular dementia.
  • Current significant traumatic brain injury (defined as the presence of any intracranial blood on Computed Tomography scan of the head or best Glasgow Coma Scale Score of less than 13 at the time of screening).
  • Current spinal cord injury with persistent neurologic deficit at the time of screening.
  • Acute stroke immediately prior to/upon admission, or emergent stroke as a new event during hospitalization.
  • Any vision or hearing impairments resulting in an inability to complete study procedures.
  • Current pregnancy, as indicated by chart review and self-report.
  • Involved in any criminal justice proceedings related to illicit substance use at time of screening.
  • Incarcerated or in police custody at time of study enrollment.
  • Admitted to the hospital with a burn affecting \>10% total body surface area, as indicated by chart review.
  • Any medical, physical, cognitive, or psychiatric conditions that would limit the participant's ability to provide informed consent or complete study procedures, as determined by study staff and/or investigators.

About University Of Wisconsin, Madison

The University of Wisconsin-Madison is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive resources, including cutting-edge facilities and a diverse pool of expert researchers, to conduct rigorous studies that address critical health challenges. The institution's focus on translating research findings into practical applications fosters the development of new treatments and interventions, ultimately contributing to improved patient outcomes and public health initiatives. As a sponsor of clinical trials, the University of Wisconsin-Madison is dedicated to upholding the highest ethical standards and ensuring participant safety throughout the research process.

Locations

Milwaukee, Wisconsin, United States

Madison, Wisconsin, United States

Patients applied

0 patients applied

Trial Officials

Randy Brown, MD, PhD

Principal Investigator

UW School of Medicine and Public Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported