Opioid MisuseSTOMP-AINCT06527599
Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention
A study testing Opioid Risk Monitoring (ORM), enhanced Trauma Care Coordination (eTCC) and Pain Coping Skills Training - Brief (PCST-LITE) in people with Opioid Misuse and Trauma Injury, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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 treatment/intervention staff) and receiving (from the perspective of the patient) an adaptive intervention for reducing… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Misuse, Trauma Injury
- What is being tested?
- Opioid Risk Monitoring (ORM), enhanced Trauma Care Coordination (eTCC) and Pain Coping Skills Training - Brief (PCST-LITE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UW Health
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention (STOMP-AI)
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.
Read the 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 prescriptions following surgery for traumatic injury. The project will operationalize a standardized approach to screening, treating, and monitoring risk of opioid misuse following traumatic injury. If funded, the project would provide a personalized approach to post-injury monitoring and management through an adaptive intervention designed to target the needs of the individual, rather than implementing a rigid, one-size-fits-all intervention model to prevent opioid misuse.
Approximately 107 participants will be enrolled into the study (approximately 54 participants at UW and 53 participants at MCW). At or very shortly after (within 1-2 days) discharge, participants will be randomized using a 2x2 factorial design to initially receive any one of the following four interventions:
- standard Trauma Care Coordination (sTCC)
- sTCC + an abbreviated Pain Coping Skills Training (PCST-Lite)
- enhanced Trauma Care Coordination (eTCC)
- eTCC + PCST-Lite
Components of the adaptive intervention will be iteratively refined at various points before, during, and after the pilot SMART in order to maximize feasibility and acceptability.
Primary Objective: Determine the feasibility of delivering an adaptive intervention for reducing rates of opioid misuse and preventing development of opioid use disorder in individuals hospitalized for traumatic injury.
Secondary Objective: Obtain the preliminary data necessary for a successful NIH R01 Application.
Exploratory Objective 1: Identify associations between the interventions delivered and opioid use/misuse.
Exploratory Objective 2: Identify associations between the interventions delivered and the physical, social, and psychological antecedents of opioid misuse.
- Conditions
- Opioid Misuse, Trauma Injury
- Being tested
- Opioid Risk Monitoring (ORM), enhanced Trauma Care Coordination (eTCC), Pain Coping Skills Training - Brief (PCST-LITE), Standard Trauma Care Coordination (sTCC), Pain Coping Skills Training - Plus (PCST+)
- Medical subject headings
- Opioid-Related Disorders, Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Risk Monitoring (ORM)Other
A brief battery of self-reported screeners for risk factors associated with opioid misuse (e.g., Current Opioid Misuse Measure; Pain, Enjoyment of life, and General activities scale; Pain Catastrophizing Scale). These measures will be administered within seven days of hospital discharge (i.e., baseline), and again at 2-, 4-, 8-, and 12-weeks following discharge to assess for ongoing risk for opioid misuse. Participants will additionally complete the self-reported Opioid Risk Tool within seven days of hospital discharge.
enhanced Trauma Care Coordination (eTCC)Behavioural
Also called Trauma Medical Home
An enhanced care management model with increased patient contact and embedded interventions based on clinical presentation and collaboration with the patient. eTCC is a telehealth-based care coordinating intervention where a care coordinator assesses the participant, creates a plan of care, collaborates with the eTCC team, follows up with a second virtual visit within a week, and communicates with the participant and care team at least bi-weekly for the 3 month intervention period.
Pain Coping Skills Training - Brief (PCST-LITE)Behavioural
PCST-LITE will consist of a single 55-minute videoconference session, in which participants will receive brief psychoeducation grounded in gate control theory, progressive muscle relaxation (PMR), and therapist-guided imagery. Participants will be asked to practice PMR and imagery daily and will receive four weeks of regular (4-5 times per week) text messaging as a reminder.
Standard Trauma Care Coordination (sTCC)Behavioural
Standard Trauma Care Coordination (sTCC) will functionally serve as a treatment-as-usual arm, as it will involve no study intervention.
Pain Coping Skills Training - Plus (PCST+)Behavioural
PCST+ will include two videoconferencing sessions, in addition to the first videoconferencing session they previously received. In session 1, participants will be taught an activity/rest cycle to schedule activities, so they are productive while avoiding increasing pain severity due to taking insufficient breaks. Session 2 centers around cognitive restructuring, involving brief psychoeducation and skills development surrounding how participants might recognize the influence that cognitions can have on pain intensity and coping. Participants will receive 3 weekly, 15-minute calls to review skills and problem-solve.
Pain Coping Skills Training - Maintenance (PCST-M)Behavioural
PCST-M consists of five weekly booster calls from the patient's study therapist to reinforce the techniques covered in the initial PCST-Lite session.
| Study group | Role | What they receive |
|---|---|---|
| PCST-Lite + eTCC re-randomized to eTCC + PCST-Plus | Experimental | Participants initially randomized to Pain Coping Skills Training-Lite (PCST-Lite) plus enhanced Trauma Care Coordination (eTCC) who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to receive eTCC and Enhanced Pain Coping Skills Training (PCST-Plus). Receives: Other: Opioid Risk Monitoring (ORM); Behavioral: enhanced Trauma Care Coordination (eTCC); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE); Behavioral: Pain Coping Skills Training - Plus (PCST+) |
| PCST-Lite + eTCC re-randomized to eTCC + PCST-M | Experimental | Participants initially randomized to PCST-Lite plus eTCC who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to receive eTCC and Pain Coping Skills Training-Maintenance (PCST-M) at 4 weeks. Receives: Other: Opioid Risk Monitoring (ORM); Behavioral: enhanced Trauma Care Coordination (eTCC); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE); Behavioral: Pain Coping Skills Training - Maintenance (PCST-M) |
| PCST-Lite + eTCC Low Risk eTCC + PCST-M | Experimental | Participants initially randomized to PCST-Lite plus eTCC who are identified to be at low risk for opioid misuse at week 4 will then receive eTCC and PCST-M. Receives: Other: Opioid Risk Monitoring (ORM); Behavioral: enhanced Trauma Care Coordination (eTCC); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE); Behavioral: Pain Coping Skills Training - Maintenance (PCST-M) |
| eTCC re-randomized to PCST-LITE | Experimental | Participants initially randomized to eTCC who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to PCST-LITE at 4 weeks. Receives: Other: Opioid Risk Monitoring (ORM); Behavioral: enhanced Trauma Care Coordination (eTCC); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE) |
| eTCC re-randomized to eTCC | Experimental | Participants initially randomized to eTCC who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to receive the same intervention at 4 weeks. Receives: Other: Opioid Risk Monitoring (ORM); Behavioral: enhanced Trauma Care Coordination (eTCC) |
| eTCC Low Risk eTCC | Experimental | Participants initially randomized to eTCC who are identified to be at low risk for opioid misuse at week 4 will continue eTCC. Receives: Other: Opioid Risk Monitoring (ORM); Behavioral: enhanced Trauma Care Coordination (eTCC) |
| PSCT-LITE re-randomized to PCST+ | Experimental | Participants initially randomized to PCST-LITE who are identified to be at elevated risk for opioid misuse at week 4 re-randomized to PCST+. Receives: Other: Opioid Risk Monitoring (ORM); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE); Behavioral: Pain Coping Skills Training - Plus (PCST+) |
| PCST-LITE re-randomized to PCST-Maintenance | Experimental | Participants initially randomized to PCST-LITE and are not re-randomized to an augmented form of PCST will instead receive PCST-Maintenance (PCST-M). Receives: Other: Opioid Risk Monitoring (ORM); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE); Behavioral: Pain Coping Skills Training - Maintenance (PCST-M) |
| PCST-Lite Low Risk PCST-M | Experimental | Participants initially randomized to PCST-Lite who are identified to be at low risk for opioid misuse at week 4 will be assigned to PCST-M. Receives: Other: Opioid Risk Monitoring (ORM); Behavioral: Pain Coping Skills Training - Maintenance (PCST-M) |
| sTCC re-randomized to PCST-LITE | Experimental | Participants initially randomized to Standard Trauma Care Coordination (sTCC) who are identified to be at elevated risk for opioid misuse at week 4 will be re-randomized to either PCST-LITE or continued sTCC. Receives: Other: Opioid Risk Monitoring (ORM); Behavioral: Pain Coping Skills Training - Brief (PCST-LITE); Behavioral: Standard Trauma Care Coordination (sTCC) |
| sTCC re-randomized to sTCC | Experimental | Participants initially randomized to sTCC who are identified to be at elevated risk for opioid misuse at week 4 will be re-randomized to either PCST-LITE or continued sTCC. Receives: Other: Opioid Risk Monitoring (ORM); Behavioral: Standard Trauma Care Coordination (sTCC) |
| sTCC Low Risk sTCC | Active comparator | Participants initially randomized to sTCC who are identified to be at low risk for opioid misuse at week 4 will continued sTCC. Receives: Other: Opioid Risk Monitoring (ORM); Behavioral: Standard Trauma Care Coordination (sTCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Target Sample Size Accrued by Study Completion
A feasibility goal is to accrue at least 70 percent of the targeted sample size by study completion.
Measured: up to 18 months
Number of Participants Enrolled
Number of participants who enrolled
Measured: baseline to 4 weeks, baseline to 12 weeks
Number of Participants Retained
Number of participants who completed the study
Measured: 4 weeks, 12 weeks
Acceptability of intervention
Participants will complete a qualitative interview regarding their experiences in the study. Responses may be used to guide future related studies.
Measured: 12 weeks
Secondary outcomes (1)
Incidence of Adverse Events by Grade
A safety objective is to evaluate the frequency and severity of adverse events associated with each arm of the intervention. Reported here is incidence of adverse events by grade.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start13 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid MisuseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pilot Sequential, Multiple-Assignment Randomized Trial (Pilot SMART)
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Wisconsin Partnership Program, Medical College of Wisconsin
- Responsible party
- Sponsor
- Investigators
- Randy Brown, MD, PhD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527599
- Sponsor's protocol ID
- 2024-0157
- Other IDs
- A532050, Protocol Version CP004
- Acronym
- STOMP-AI
- Status last verified
- Jun 2026
- First submitted
- 25 Jul 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Horton DM, Leinweber DL, Salihu E, Sarwar T, Muller H, Trevino C, Zaborek J, Chen G, Quanbeck A, Somers T, Almirall D, Zarzaur B, Brown RT. Screen-and-treat in trauma for opioid misuse prevention using an adaptive intervention (STOMP-AI): Protocol for a pilot sequential, multiple assignment, randomized trial. Contemp Clin Trials. 2026 Apr;163:108255. doi: 10.1016/j.cct.2026.108255. Epub 2026 Feb 11.
PubMed 41688015
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention (STOMP-AI)
- ClinicalTrials.gov ID
- NCT06527599
- Acronym / sponsor ID
- STOMP-AI / 2024-0157
- Conditions
- Opioid Misuse, Trauma Injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Wisconsin Partnership Program, Medical College of Wisconsin
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 prescriptions following surgery for traumatic injury. The project will operationalize a standardized approach to screening, treating, and monitoring risk of opioid misuse following traumatic injury. If funded, the project would provide a personalized approach to post-injury monitoring and management through an adaptive intervention designed to target the needs of the individual, rather than implementing a rigid, one-size-fits-all intervention model to prevent opioid misuse.
Approximately 107 participants will be enrolled into the study (approximately 54 participants at UW and 53 participants at MCW). At or very shortly after (within 1-2 days) discharge, participants will be randomized using a 2x2 factorial design to initially receive any one of the following four interventions:
- standard Trauma Care Coordination (sTCC)
- sTCC + an abbreviated Pain Coping Skills Training (PCST-Lite)
- enhanced Trauma Care Coordination (eTCC)
- eTCC + PCST-Lite
Components of the adaptive intervention will be iteratively refined at various points before, during, and after the pilot SMART in order to maximize feasibility and acceptability.
Primary Objective: Determine the feasibility of delivering an adaptive intervention for reducing rates of opioid misuse and preventing development of opioid use disorder in individuals hospitalized for traumatic injury.
Secondary Objective: Obtain the preliminary data necessary for a successful NIH R01 Application.
Exploratory Objective 1: Identify associations between the interventions delivered and opioid use/misuse.
Exploratory Objective 2: Identify associations between the interventions delivered and the physical, social, and psychological antecedents of opioid misuse.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 12
- Model description
- Pilot Sequential, Multiple-Assignment Randomized Trial (Pilot SMART)
| Arm | Type | Receives |
|---|---|---|
| PCST-Lite + eTCC re-randomized to eTCC + PCST-Plus | Experimental | Other: Opioid Risk Monitoring (ORM), Behavioral: enhanced Trauma Care Coordination (eTCC), Behavioral: Pain Coping Skills Training - Brief (PCST-LITE), Behavioral: Pain Coping Skills Training - Plus (PCST+)Participants initially randomized to Pain Coping Skills Training-Lite (PCST-Lite) plus enhanced Trauma Care Coordination (eTCC) who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to receive eTCC and Enhanced Pain Coping Skills Training (PCST-Plus). |
| PCST-Lite + eTCC re-randomized to eTCC + PCST-M | Experimental | Other: Opioid Risk Monitoring (ORM), Behavioral: enhanced Trauma Care Coordination (eTCC), Behavioral: Pain Coping Skills Training - Brief (PCST-LITE), Behavioral: Pain Coping Skills Training - Maintenance (PCST-M)Participants initially randomized to PCST-Lite plus eTCC who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to receive eTCC and Pain Coping Skills Training-Maintenance (PCST-M) at 4 weeks. |
| PCST-Lite + eTCC Low Risk eTCC + PCST-M | Experimental | Other: Opioid Risk Monitoring (ORM), Behavioral: enhanced Trauma Care Coordination (eTCC), Behavioral: Pain Coping Skills Training - Brief (PCST-LITE), Behavioral: Pain Coping Skills Training - Maintenance (PCST-M)Participants initially randomized to PCST-Lite plus eTCC who are identified to be at low risk for opioid misuse at week 4 will then receive eTCC and PCST-M. |
| eTCC re-randomized to PCST-LITE | Experimental | Other: Opioid Risk Monitoring (ORM), Behavioral: enhanced Trauma Care Coordination (eTCC), Behavioral: Pain Coping Skills Training - Brief (PCST-LITE)Participants initially randomized to eTCC who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to PCST-LITE at 4 weeks. |
| eTCC re-randomized to eTCC | Experimental | Other: Opioid Risk Monitoring (ORM), Behavioral: enhanced Trauma Care Coordination (eTCC)Participants initially randomized to eTCC who are identified to be at elevated risk for opioid misuse at week 4 may be re-randomized to receive the same intervention at 4 weeks. |
| eTCC Low Risk eTCC | Experimental | Other: Opioid Risk Monitoring (ORM), Behavioral: enhanced Trauma Care Coordination (eTCC)Participants initially randomized to eTCC who are identified to be at low risk for opioid misuse at week 4 will continue eTCC. |
| PSCT-LITE re-randomized to PCST+ | Experimental | Other: Opioid Risk Monitoring (ORM), Behavioral: Pain Coping Skills Training - Brief (PCST-LITE), Behavioral: Pain Coping Skills Training - Plus (PCST+)Participants initially randomized to PCST-LITE who are identified to be at elevated risk for opioid misuse at week 4 re-randomized to PCST+. |
| PCST-LITE re-randomized to PCST-Maintenance | Experimental | Other: Opioid Risk Monitoring (ORM), Behavioral: Pain Coping Skills Training - Brief (PCST-LITE), Behavioral: Pain Coping Skills Training - Maintenance (PCST-M)Participants initially randomized to PCST-LITE and are not re-randomized to an augmented form of PCST will instead receive PCST-Maintenance (PCST-M). |
| PCST-Lite Low Risk PCST-M | Experimental | Other: Opioid Risk Monitoring (ORM), Behavioral: Pain Coping Skills Training - Maintenance (PCST-M)Participants initially randomized to PCST-Lite who are identified to be at low risk for opioid misuse at week 4 will be assigned to PCST-M. |
| sTCC re-randomized to PCST-LITE | Experimental | Other: Opioid Risk Monitoring (ORM), Behavioral: Pain Coping Skills Training - Brief (PCST-LITE), Behavioral: Standard Trauma Care Coordination (sTCC)Participants initially randomized to Standard Trauma Care Coordination (sTCC) who are identified to be at elevated risk for opioid misuse at week 4 will be re-randomized to either PCST-LITE or continued sTCC. |
| sTCC re-randomized to sTCC | Experimental | Other: Opioid Risk Monitoring (ORM), Behavioral: Standard Trauma Care Coordination (sTCC)Participants initially randomized to sTCC who are identified to be at elevated risk for opioid misuse at week 4 will be re-randomized to either PCST-LITE or continued sTCC. |
| sTCC Low Risk sTCC | Active comparator | Other: Opioid Risk Monitoring (ORM), Behavioral: Standard Trauma Care Coordination (sTCC)Participants initially randomized to sTCC who are identified to be at low risk for opioid misuse at week 4 will continued sTCC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Expected to be in control of their own medications at the time of discharge from the controlled environment of hospital or short-term rehabilitation.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid Risk Monitoring (ORM)A brief battery of self-reported screeners for risk factors associated with opioid misuse (e.g., Current Opioid Misuse Measure; Pain, Enjoyment of life, and General activities scale; Pain Catastrophizing Scale). These measures will be administered within seven days of hospital discharge (i.e., baseline), and again at 2-, 4-, 8-, and 12-weeks following discharge to assess for ongoing risk for opioid misuse. Participants will additionally complete the self-reported Opioid Risk Tool within seven days of hospital discharge. | Other | PCST-LITE re-randomized to PCST-Maintenance, PCST-Lite + eTCC Low Risk eTCC + PCST-M, PCST-Lite + eTCC re-randomized to eTCC + PCST-M, PCST-Lite + eTCC re-randomized to eTCC + PCST-Plus, PCST-Lite Low Risk PCST-M, PSCT-LITE re-randomized to PCST+, eTCC Low Risk eTCC, eTCC re-randomized to PCST-LITE, eTCC re-randomized to eTCC, sTCC Low Risk sTCC, sTCC re-randomized to PCST-LITE, sTCC re-randomized to sTCC |
| enhanced Trauma Care Coordination (eTCC)Also: Trauma Medical HomeAn enhanced care management model with increased patient contact and embedded interventions based on clinical presentation and collaboration with the patient. eTCC is a telehealth-based care coordinating intervention where a care coordinator assesses the participant, creates a plan of care, collaborates with the eTCC team, follows up with a second virtual visit within a week, and communicates with the participant and care team at least bi-weekly for the 3 month intervention period. | Behavioural | PCST-Lite + eTCC Low Risk eTCC + PCST-M, PCST-Lite + eTCC re-randomized to eTCC + PCST-M, PCST-Lite + eTCC re-randomized to eTCC + PCST-Plus, eTCC Low Risk eTCC, eTCC re-randomized to PCST-LITE, eTCC re-randomized to eTCC |
| Pain Coping Skills Training - Brief (PCST-LITE)PCST-LITE will consist of a single 55-minute videoconference session, in which participants will receive brief psychoeducation grounded in gate control theory, progressive muscle relaxation (PMR), and therapist-guided imagery. Participants will be asked to practice PMR and imagery daily and will receive four weeks of regular (4-5 times per week) text messaging as a reminder. | Behavioural | PCST-LITE re-randomized to PCST-Maintenance, PCST-Lite + eTCC Low Risk eTCC + PCST-M, PCST-Lite + eTCC re-randomized to eTCC + PCST-M, PCST-Lite + eTCC re-randomized to eTCC + PCST-Plus, PSCT-LITE re-randomized to PCST+, eTCC re-randomized to PCST-LITE, sTCC re-randomized to PCST-LITE |
| Standard Trauma Care Coordination (sTCC)Standard Trauma Care Coordination (sTCC) will functionally serve as a treatment-as-usual arm, as it will involve no study intervention. | Behavioural | sTCC Low Risk sTCC, sTCC re-randomized to PCST-LITE, sTCC re-randomized to sTCC |
| Pain Coping Skills Training - Plus (PCST+)PCST+ will include two videoconferencing sessions, in addition to the first videoconferencing session they previously received. In session 1, participants will be taught an activity/rest cycle to schedule activities, so they are productive while avoiding increasing pain severity due to taking insufficient breaks. Session 2 centers around cognitive restructuring, involving brief psychoeducation and skills development surrounding how participants might recognize the influence that cognitions can have on pain intensity and coping. Participants will receive 3 weekly, 15-minute calls to review skills and problem-solve. | Behavioural | PCST-Lite + eTCC re-randomized to eTCC + PCST-Plus, PSCT-LITE re-randomized to PCST+ |
| Pain Coping Skills Training - Maintenance (PCST-M)PCST-M consists of five weekly booster calls from the patient's study therapist to reinforce the techniques covered in the initial PCST-Lite session. | Behavioural | PCST-LITE re-randomized to PCST-Maintenance, PCST-Lite + eTCC Low Risk eTCC + PCST-M, PCST-Lite + eTCC re-randomized to eTCC + PCST-M, PCST-Lite Low Risk PCST-M |
Primary outcome
Percent of Target Sample Size Accrued by Study Completion
Time frame: up to 18 months
A feasibility goal is to accrue at least 70 percent of the targeted sample size by study completion.
Number of Participants Enrolled
Time frame: baseline to 4 weeks, baseline to 12 weeks
Number of participants who enrolled
Number of Participants Retained
Time frame: 4 weeks, 12 weeks
Number of participants who completed the study
Acceptability of intervention
Time frame: 12 weeks
Participants will complete a qualitative interview regarding their experiences in the study. Responses may be used to guide future related studies.
1 secondary outcome
Incidence of Adverse Events by Grade
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Derived from this study: PubMed 41688015Horton DM, Leinweber DL, Salihu E, Sarwar T, Muller H, Trevino C, Zaborek J, Chen G, Quanbeck A, Somers T, Almirall D, Zarzaur B, Brown RT. Screen-and-treat in trauma for opioid misuse prevention using an adaptive intervention (STOMP-AI): Protocol for a pilot sequential, multiple assignment, randomized trial. Contemp Clin Trials. 2026 Apr;163:108255. doi: 10.1016/j.cct.2026.108255. Epub 2026 Feb 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randy Brown, MD, PhD principal investigator
UW School of Medicine and Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Risk Monitoring (ORM), enhanced Trauma Care Coordination (eTCC) and Pain Coping Skills Training - Brief (PCST-LITE) in people with Opioid Misuse and Trauma Injury, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Target Sample Size Accrued by Study Completion (time frame: up to 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06527599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.