Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06527599

Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention

Led by University of Wisconsin, Madison · Updated on 2025-08-06

107

Participants Needed

2

Research Sites

93 weeks

Total Duration

On this page

Sponsors

U

University of Wisconsin, Madison

Lead Sponsor

W

Wisconsin Partnership Program

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to speak, read, and write fluently in English
  • Admitted to hospital for a traumatic injury at time of screening
  • Injury severity score of 9 or greater
  • Received 40 mg morphine milligram equivalent within 48 hours before screening or discharged with an opioid prescription
  • Expected to be in control of own medications at discharge from hospital or short-term rehabilitation
Not Eligible

You will not qualify if you...

  • Unable to provide written consent
  • Current diagnosis of cancer with life expectancy less than 12 months
  • Current prescription for opioid use disorder treatment and diagnosis not in remission
  • History of dementing illnesses or neurodegenerative diseases (e.g., Alzheimer's, Parkinson's, vascular dementia)
  • Significant traumatic brain injury at screening
  • Current spinal cord injury with persistent neurologic deficit
  • Acute or emergent stroke during hospitalization
  • Vision or hearing impairments preventing study participation
  • Current pregnancy
  • Involved in criminal justice proceedings related to illicit substance use
  • Incarcerated or in police custody at enrollment
  • Hospital admission with burns affecting more than 10% of body surface area
  • Medical, physical, cognitive, or psychiatric conditions limiting informed consent or study completion

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

UW Health

Madison, Wisconsin, United States, 53792

Actively Recruiting

2

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

E

Ejura Salihu, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

12

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