Status:
RECRUITING
Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Wisconsin Partnership Program
Medical College of Wisconsin
Conditions:
Opioid Misuse
Trauma Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 trea...
Detailed Description
The proposed project would be the first clinical trial to assess the feasibility of implementing a preventative treatment design that specifically targets the needs of individuals receiving opioid pre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT06527599
Start Date
August 13 2024
End Date
June 1 2026
Last Update
August 6 2025
Active Locations (2)
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1
UW Health
Madison, Wisconsin, United States, 53792
2
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226