RECRUITING

Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-13

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06527599

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Mary M Checovich, MS, CCRC

CONTACT

608-263-2653

mary.checovich@fammed.wisc.edu

Principal Investigator

Randy Brown, MD, PhD

PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Study Locations (Sites)

UW Health

Madison, Wisconsin, 53792

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-13

Study Completion Date2026-04

Study Record Updates

Study Start Date2024-08-13

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Opioid Misuse
Trauma Injury