Opioid Use DisorderSTOMPNCT02861976
Screening in Trauma for Opioid Misuse Prevention
An observational study of Opioid Use Disorder, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The current study seeks to begin the crucial work of creating effective protocols to prevent opioid misuse, addiction, and related complications by developing and pilot testing an opioid risk screening protocol at Wisconsin trauma centers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Opioid risk screen development & implementation
- How many people
- 346 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2016to 1 Jun 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients of UW Trauma Inpatient Service with expected need for post discharge with outpatient opioid analgesia.
Who may be able to join
- Inpatient victim of traumatic injury
- Expected need for post-discharge outpatient opioid analgesia
- English speaking
- Disposition to short-term rehabilitation facility is allowed
Who cannot join
- Disposition to a skilled nursing or long-term acute care facility
- Current active opioid use disorder or current active participation in a program of recovery for another substance use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53715
About this study
Official title: Screening in Trauma for Opioid Misuse Prevention (STOMP): Screen Development and Pilot Implementation Study
The current study seeks to begin the crucial work of creating effective protocols to prevent opioid misuse, addiction, and related complications by developing and pilot testing an opioid risk screening protocol at Wisconsin trauma centers.
- Conditions
- Opioid Use Disorder
- Being tested
- Opioid risk screen development & implementation
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid risk screen development & implementationOther
Development of a screening tool for the risk of opioid misuse in patients with traumatic injury.
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use disorder (CIDI-SAM) or opioid misuse (COMM) Opioid Use Disorder in 6 Months Post Traumatic Injury
This data will be analyzed in tandem with patient demographics, physical and mental health, and hypothesized risk factors for opioid misuse.
Measured: 6 months subject participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start15 Jul 2016
- Primary completion23 May 2019
- Study completion1 Jun 2020
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 Use DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 346 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall Brown, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861976
- Sponsor's protocol ID
- 2016-0430
- Other IDs
- 3152, A532050, SMPH/FAMILY MEDICINE/CL-WINGRA, Protocol Version 9/5/2019
- Acronym
- STOMP
- Status last verified
- Jun 2020
- First submitted
- 9 Feb 2016
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brown R, Deyo B, Riley C, Quanbeck A, Glass JE, Turpin R, Hetzel S, Nicholas C, Cruz M, Agarwal S. Screening in Trauma for Opioid Misuse Prevention (STOMP): study protocol for the development of an opioid risk screening tool for victims of injury. Addict Sci Clin Pract. 2017 Dec 4;12(1):28. doi: 10.1186/s13722-017-0097-6.
PubMed 29198186
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening in Trauma for Opioid Misuse Prevention (STOMP): Screen Development and Pilot Implementation Study
- ClinicalTrials.gov ID
- NCT02861976
- Acronym / sponsor ID
- STOMP / 2016-0430
- Conditions
- Opioid Use Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 10 Aug 2016 (estimated)
- 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 current study seeks to begin the crucial work of creating effective protocols to prevent opioid misuse, addiction, and related complications by developing and pilot testing an opioid risk screening protocol at Wisconsin trauma centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of UW Trauma Inpatient Service with expected need for post discharge with outpatient opioid analgesia.
Key inclusion criteria (4 listed)
- Inpatient victim of traumatic injury
- Expected need for post-discharge outpatient opioid analgesia
- English speaking
- Disposition to short-term rehabilitation facility is allowed
Key exclusion criteria (2 listed)
- Disposition to a skilled nursing or long-term acute care facility
- Current active opioid use disorder or current active participation in a program of recovery for another substance use disorder
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 screen development & implementationDevelopment of a screening tool for the risk of opioid misuse in patients with traumatic injury. | Other | – |
Primary outcome
Opioid use disorder (CIDI-SAM) or opioid misuse (COMM) Opioid Use Disorder in 6 Months Post Traumatic Injury
Time frame: 6 months subject participation
This data will be analyzed in tandem with patient demographics, physical and mental health, and hypothesized risk factors for opioid misuse.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Derived from this study: PubMed 29198186Brown R, Deyo B, Riley C, Quanbeck A, Glass JE, Turpin R, Hetzel S, Nicholas C, Cruz M, Agarwal S. Screening in Trauma for Opioid Misuse Prevention (STOMP): study protocol for the development of an opioid risk screening tool for victims of injury. Addict Sci Clin Pract. 2017 Dec 4;12(1):28. doi: 10.1186/s13722-017-0097-6.
- 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.
Randall Brown, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder, run by University of Wisconsin, Madison at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Opioid use disorder (CIDI-SAM) or opioid misuse (COMM) Opioid Use Disorder in 6 Months Post Traumatic Injury (time frame: 6 months subject participation). 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 NCT02861976, 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 17 Jun 2020; AzTrials last refreshed its copy on 31 Oct 2026.