Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention

Description

The primary objective of the present pilot, sequential, multiple-assignment randomized trial (Pilot SMART) is to determine feasibility and acceptability of delivering (from the perspective of the treatment/intervention staff) and receiving (from the perspective of the patient) an adaptive intervention for reducing rates of opioid misuse and preventing development of opioid use disorder in individuals hospitalized for traumatic injury. A complimentary secondary objective is to ensure the feasibility of conducting a future, multi-site, full-scale SMART. Approximately 107 participants will be enrolled and can expect to be on study for up to 6 months.

Conditions

Opioid Misuse, Trauma Injury

Study Overview

Study Details

Study overview

The primary objective of the present pilot, sequential, multiple-assignment randomized trial (Pilot SMART) is to determine feasibility and acceptability of delivering (from the perspective of the treatment/intervention staff) and receiving (from the perspective of the patient) an adaptive intervention for reducing rates of opioid misuse and preventing development of opioid use disorder in individuals hospitalized for traumatic injury. A complimentary secondary objective is to ensure the feasibility of conducting a future, multi-site, full-scale SMART. Approximately 107 participants will be enrolled and can expect to be on study for up to 6 months.

Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention (STOMP-AI)

Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention

Condition
Opioid Misuse
Intervention / Treatment

-

Contacts and Locations

Madison

UW Health, Madison, Wisconsin, United States, 53792

Milwaukee

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Wisconsin, Madison,

Randy Brown, MD, PhD, PRINCIPAL_INVESTIGATOR, UW School of Medicine and Public Health

Study Record Dates

2026-04