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| ID | Type | Description | Link |
|---|---|---|---|
| UG3DA050173 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of the study is to develop and test innovative interventions to prevent the development of opioid misuse and opioid use disorders among older adolescents and young adults (AYA; ages 16-30) who use opioids, which will be initiated from a health care visit in the emergency department and extended post discharge via a telehealth approach. This study will have significant impact by identifying optimal, cost-effective opioid prevention strategies to sustain outcomes among AYAs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief intervention (BI) then Portal | Experimental | The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake. |
|
| Brief intervention (BI) then Enhanced Usual Care (EUC) | Experimental | The BI will be delivered at intake and EUC will be added 4 weeks later. |
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| Enhanced Usual Care (EUC) then Portal | Experimental | EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake. |
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| Enhanced Usual Care (EUC) then EUC | Active Comparator | EUC will be delivered at intake and delivered again 4 weeks later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief intervention (BI) | Behavioral | A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in opioid misuse | Alcohol Smoking and Substance Involvement Screening Test severity score (prescription opioids/heroin, scores range 0-27 per subscale, higher score indicates worse outcomes) | 3, 6, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in days of opioid misuse | Addiction Severity Index (modified; score ranges from 0-60, higher score indicates worse outcomes) | 3, 6, and 12 months |
| Change in overdose risk behaviors | Opioid-related risk behaviors (score ranges from 0-32, higher score indicates worse outcomes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maureen Walton, PhD | University of Michigan | Principal Investigator |
| Erin Bonar, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41085955 | Derived | Kuklinski MR, Gibbons BJ, Bowser DM, McCollister KE, Smart R, Dunlap LJ, Shenkar E, Bonar EE, Boomer T, Campbell M, Fiellin LE, Hutton DW, Rao V, Saldana L, Su K, Walton MA, Yilmazer T. Investing in Interventions to Prevent Opioid Use Disorder in Adolescents and Young Adults: Start-up Costs from NIDA's HEAL Prevention Initiative. Prev Sci. 2025 Nov;26(7):1045-1055. doi: 10.1007/s11121-025-01835-6. Epub 2025 Oct 14. | |
| 38331586 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 27, 2026 | |
| Reset | Apr 16, 2026 | |
| Release | May 12, 2026 | |
| Reset | Jun 8, 2026 | |
| Release | Jun 11, 2026 | |
| Reset | Jul 8, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2023 | Mar 11, 2024 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 27, 2026 | Apr 16, 2026 | |||
| May 12, 2026 |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Portal | Behavioral | Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks. |
|
| Enhanced Usual Care (EUC) | Behavioral | The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print. |
|
| 3, 6, and 12 months |
| Change in other drug and alcohol use | Substance use index (based on frequency measures, higher scores indicate worse outcome) | 3, 6, and 12 months |
| Change in substance use consequences | Adapted alcohol, cannabis, and/or opioid-related consequences (total, higher score indicates worse outcomes) | 3, 6, and 12 months |
| Change in impaired driving | Adapted items from Young Adult Driving Questionnaire (5 items; score ranges from 0-30; higher score indicates worse outcome) | 3, 6, and 12 months |
| Seewald L, Bonar E, Bohnert ASB, Carter PM, King CA, Losman ED, Bacon L, Wheeler T, Walton M. Lifetime non-fatal overdose experiences among at-risk adolescents and young adults in the emergency department with past-year opioid use in the USA. Inj Prev. 2024 Oct 1;30(5):373-380. doi: 10.1136/ip-2023-045072. |
| 34352386 | Derived | Bonar EE, Kidwell KM, Bohnert ASB, Bourque CA, Carter PM, Clark SJ, Glantz MD, King CA, Losman ED, McCabe SE, Philyaw-Kotov ML, Prosser LA, Voepel-Lewis T, Zheng K, Walton MA. Optimizing scalable, technology-supported behavioral interventions to prevent opioid misuse among adolescents and young adults in the emergency department: A randomized controlled trial protocol. Contemp Clin Trials. 2021 Sep;108:106523. doi: 10.1016/j.cct.2021.106523. Epub 2021 Aug 2. |
| Jun 8, 2026 |
| Jun 11, 2026 | Jul 8, 2026 |
| Jul 8, 2026 |