OverdoseNCT07797933
A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3
A study testing Brief youth overdose prevention education in people with Overdose, run by Boston Medical Center at 1 site in United States.
Trial summary
Between 2015 and 2019, overdose deaths translated to 1.25 million years of life lost among adolescents and young adults (youth) aged 12 to 24 years, and the percent change in fatal overdose rates among adolescents ages 14 to 18 was higher than adults between 2019 and 2020.3-5 Primary care providers are uniquely… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Overdose
- What is being tested?
- Brief youth overdose prevention education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Dec 2029
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Providers:
- Physicians and advance practice providers (nurse practitioners and physician assistants) within Pediatric Primary Care and Family Medicine at Boston Medical Center, NeighborHealth, and South Boston Community Health Center
- ≥ 1 clinic session per week
- Youth:
- Ages 13 - 26
- Scheduled for a CPE or follow-up clinical appointment with a provider who is participating in the trial
- English speaking
Who cannot join
- Providers:
- Participated as an intervention provider in the R61 pilot RCT (H-45731)
- Participated in the Community Advisory Board that assisted in the development of the intervention (H-45388)
- Youth:
- Caregivers of youth ages 13-17 unable to provide informed consent or are not English speaking
- Cognitive limitation or intellectual disability that in the opinion of their provider would not be able to complete the requirements of the research
Show all 10Show fewer
- Young adults ages 18-26 with a legal guardian
- Any medical/psychiatric condition that causes acute distress and requires emergency evaluation
- Under legal custody of the Department of Children and Families (DCF)
- Participated in the intervention arm of the R61 pilot RCT (H-45731)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston Medical Center
Boston, Massachusetts, 02118
Sarah Bagley, MD, 617-414-7399, sarah.bagley@bmc.org
About this study
Between 2015 and 2019, overdose deaths translated to 1.25 million years of life lost among adolescents and young adults (youth) aged 12 to 24 years, and the percent change in fatal overdose rates among adolescents ages 14 to 18 was higher than adults between 2019 and 2020.3-5 Primary care providers are uniquely positioned to provide evidence-based information to youth to both improve awareness of overdose risk (individual benefit) and simultaneously ensure that youth are prepared to recognize and respond to an overdose (public health benefit). However, currently there is no evidence-based intervention for pediatric primary care to reduce youth overdose risk and ensure youth can recognize and respond to an overdose.
To address the gap in evidence-based overdose prevention interventions for youth, the investigators propose a randomized controlled trial (RCT) to evaluate the efficacy of a brief universal overdose prevention intervention in pediatric primary care. 24 providers and 624 youth patient participants randomized (at the provider level) to receive either the brief overdose prevention intervention or usual care will be enrolled.
- Conditions
- Overdose
- Being tested
- Brief youth overdose prevention education, Usual Standard of Care
- Keywords
- Brief overdose prevention, Naloxone, Youth parents, Health care providers, Primary care
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief youth overdose prevention educationBehavioural
Providers in the intervention group will inform youth participants about: the risk factors for overdose, how to stay safe and prevent overdose, how to recognize an overdose, and how to respond to an overdose. Providers in the intervention group will also inform youth participants how to use naloxone and facilitate access if youth would like to have it.
Usual Standard of CareOther
Youth participants will be provided usual care by providers in the control group. As part of usual care, providers may facilitate access to naloxone for youth control participants if they would like to have it.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Providers randomized to the intervention group will complete two 30-minute trainings in person or over Teams via videoconference. In the first training, providers will receive overdose prevention education and learn about the brief overdose prevention intervention. In the second training, providers will practice conducting the intervention and filling out the fidelity checklist that will be completed at the end of each appointment. Receives: Behavioral: Brief youth overdose prevention education |
| Control group | Active comparator | Providers randomized to the control group will conduct the youths' comprehensive physical exam (CPE) or follow-up clinical appointment as usual. Receives: Other: Usual Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Fidelity to the Intervention
Providers in the intervention arm will complete a checklist after all CPEs and follow-up clinical appointments with youth ages 13 to 26 years. The checklist will assess provider consistency in delivery of the intervention including adherence to intervention topics and the provision of naloxone.
Measured: 12 months
Youth Fidelity to the Intervention
Youth in the intervention arm will complete a checklist after their CPEs and follow-up clinical appointments. The checklist will assess consistency in intervention delivery including adherence to intervention topics and whether naloxone was offered to the youth.
Measured: 12 months
Youth knowledge of risk associated with exposure to fentanyl and other emerging drugs
Assessed using a 4-point Likert-scale question measuring perceived risk of harm from taking prescription medication that was not prescribed or taking medication other than prescribed.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Secondary outcomes (2)
Youth knowledge of strategies to reduce overdose risk
Assessed using 4-point Likert-scale questions measuring perceived risk associated with using more than one substance at a time and using substances while alone.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Youth's ability to recognize and respond to an overdose
Assessed using investigator-developed knowledge assessment questions evaluating recognition of overdose signs, appropriate overdose response, and knowledge of naloxone.
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverdoseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm cluster RCT will be conducted. Randomization will occur at the provider level. After enrollment, a 2-block randomization will be done to ensure that randomization to the intervention is balanced across provider types (e.g., family medicine vs. pediatrics). .
- Masking
- None (open label)
- Enrolment
- 648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sarah Bagley, MD, Principal investigator, Boston Medical Center, Internal Medicine, Addiction MedicineAmy Yule, MD, Principal investigator, Boston Medical Center, Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797933
- Sponsor's protocol ID
- H-46999
- Other IDs
- R61DA062217
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3
- ClinicalTrials.gov ID
- NCT07797933
- Acronym / sponsor ID
- H-46999
- Conditions
- Overdose
- Keywords
- Brief overdose prevention, Naloxone, Youth parents, Health care providers, Primary care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 648 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 1 Sep 2026 (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.
Between 2015 and 2019, overdose deaths translated to 1.25 million years of life lost among adolescents and young adults (youth) aged 12 to 24 years, and the percent change in fatal overdose rates among adolescents ages 14 to 18 was higher than adults between 2019 and 2020.3-5 Primary care providers are uniquely positioned to provide evidence-based information to youth to both improve awareness of overdose risk (individual benefit) and simultaneously ensure that youth are prepared to recognize and respond to an overdose (public health benefit). However, currently there is no evidence-based intervention for pediatric primary care to reduce youth overdose risk and ensure youth can recognize and respond to an overdose.
To address the gap in evidence-based overdose prevention interventions for youth, the investigators propose a randomized controlled trial (RCT) to evaluate the efficacy of a brief universal overdose prevention intervention in pediatric primary care. 24 providers and 624 youth patient participants randomized (at the provider level) to receive either the brief overdose prevention intervention or usual care will be enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-arm cluster RCT will be conducted. Randomization will occur at the provider level. After enrollment, a 2-block randomization will be done to ensure that randomization to the intervention is balanced across provider types (e.g., family medicine vs. pediatrics). .
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Brief youth overdose prevention educationProviders randomized to the intervention group will complete two 30-minute trainings in person or over Teams via videoconference. In the first training, providers will receive overdose prevention education and learn about the brief overdose prevention intervention. In the second training, providers will practice conducting the intervention and filling out the fidelity checklist that will be completed at the end of each appointment. |
| Control group | Active comparator | Other: Usual Standard of CareProviders randomized to the control group will conduct the youths' comprehensive physical exam (CPE) or follow-up clinical appointment as usual. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Physicians and advance practice providers (nurse practitioners and physician assistants) within Pediatric Primary Care and Family Medicine at Boston Medical Center, NeighborHealth, and South Boston Community Health Center
- ≥ 1 clinic session per week
- Ages 13 - 26
- Scheduled for a CPE or follow-up clinical appointment with a provider who is participating in the trial
- English speaking
Key exclusion criteria (10 listed)
- Participated as an intervention provider in the R61 pilot RCT (H-45731)
- Participated in the Community Advisory Board that assisted in the development of the intervention (H-45388)
- Caregivers of youth ages 13-17 unable to provide informed consent or are not English speaking
- Cognitive limitation or intellectual disability that in the opinion of their provider would not be able to complete the requirements of the research
- Young adults ages 18-26 with a legal guardian
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 |
|---|---|---|
| Brief youth overdose prevention educationProviders in the intervention group will inform youth participants about: the risk factors for overdose, how to stay safe and prevent overdose, how to recognize an overdose, and how to respond to an overdose. Providers in the intervention group will also inform youth participants how to use naloxone and facilitate access if youth would like to have it. | Behavioural | Intervention group |
| Usual Standard of CareYouth participants will be provided usual care by providers in the control group. As part of usual care, providers may facilitate access to naloxone for youth control participants if they would like to have it. | Other | Control group |
Primary outcome
Provider Fidelity to the Intervention
Time frame: 12 months
Providers in the intervention arm will complete a checklist after all CPEs and follow-up clinical appointments with youth ages 13 to 26 years. The checklist will assess provider consistency in delivery of the intervention including adherence to intervention topics and the provision of naloxone.
Youth Fidelity to the Intervention
Time frame: 12 months
Youth in the intervention arm will complete a checklist after their CPEs and follow-up clinical appointments. The checklist will assess consistency in intervention delivery including adherence to intervention topics and whether naloxone was offered to the youth.
Youth knowledge of risk associated with exposure to fentanyl and other emerging drugs
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Assessed using a 4-point Likert-scale question measuring perceived risk of harm from taking prescription medication that was not prescribed or taking medication other than prescribed.
2 secondary outcomes
Youth knowledge of strategies to reduce overdose risk
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Youth's ability to recognize and respond to an overdose
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 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 Oct 2026.
- 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.
Sarah Bagley, MD principal investigator
Boston Medical Center, Internal Medicine, Addiction Medicine
Amy Yule, MD principal investigator
Boston Medical Center, Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief youth overdose prevention education in people with Overdose, run by Boston Medical Center 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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 1 Oct 2026. 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?
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?
Contact Sarah Bagley, MD, MSc ((617) 414-7399, sarah.bagley@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider Fidelity to the Intervention (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.