OverdoseNCT07022717
A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk
A study testing Brief youth overdose prevention education and Information about Naloxone in people with Overdose, run by Boston Medical Center at 1 site in United States.
Trial summary
Adolescent (ages 10-19) overdose deaths are the third leading cause of pediatric death and continue to rise in the United States. Healthcare providers have regular and trusted relationships with youth and have experience in providing public health injury prevention counseling. 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 and Information about Naloxone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2025to Nov 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physicians and advance practice providers within Pediatric Primary Care and Family Medicine at Boston Medical Center (BMC)
- ≥ 2 clinic sessions per/week
- Ages 13-26
- Scheduled for a comprehensive physical exam with a provider who is participating in the trial
- English speaking
Who cannot join
- None
- 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
- Any medical/psychiatric condition that causes acute distress and requires emergency evaluation
- Under legal custody of the Department of Children and Families (DCF)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Medical Center, Pediatric Primary Care & Family Medicine
Boston, Massachusetts, 02118
About this study
Official title: A Universal Primary Care Based Pilot Intervention to Reduce Youth Overdose Risk
Adolescent (ages 10-19) overdose deaths are the third leading cause of pediatric death and continue to rise in the United States. Healthcare providers have regular and trusted relationships with youth and have experience in providing public health injury prevention counseling. Youth have different motivations for using drugs, and many who experience fatal overdose do not have a history of opioid use. Primary care pediatric providers regularly provide developmentally appropriate injury prevention counseling for leading causes of pediatric fatal and nonfatal injury such as drowning prevention and firearms safety. However, there are no recommended, evidence-based overdose prevention interventions for youth, including in health care settings, even though research supports pediatricians and youth-serving clinicians providing harm reduction strategies such as naloxone distribution and overdose education. Among adults, overdose prevention education reduces overdose, is cost-effective, and can be learned by laypersons. Content commonly includes awareness of fentanyl in the drug supply, risk reduction (e.g., not using alone, risks of polysubstance use), and how to recognize and respond to an overdose, including the use of naloxone.
This study is a pilot two-arm cluster randomized controlled trial (RCT) of a brief overdose prevention education intervention that will be developed in collaboration with the Community Advisory Board (CAB). The primary outcome of this study is to assess the feasibility and acceptability of the brief youth overdose prevention intervention as measured by provider feasibility and acceptability as well as youth acceptability.
- Conditions
- Overdose
- Being tested
- Brief youth overdose prevention education, Information about Naloxone, Usual standard of care
- Keywords
- Brief overdose prevention, Naloxone, Youth patients, 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.
Information about NaloxoneOther
Also called Narcan
Providers in the intervention group will inform youth participants how to use naloxone and offered a kit to take home.
Usual standard of careOther
Participants will be provided usual care by providers in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Providers randomized into this arm will complete a 45-minute intervention training. The training will occur either in person or via Zoom teleconference and include overdose prevention education, the pilot brief overdose prevention education intervention, intervention practice, and how to complete the fidelity checklist to be completed at the end of each visit. Receives: Behavioral: Brief youth overdose prevention education; Other: Information about Naloxone |
| Control group | Active comparator | Providers randomized into this arm will deliver usual care to the youth patients. Receives: Other: Usual standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the brief overdose prevention education intervention
Providers in the intervention arm will complete a checklist after all comprehensive physical exams with youth ages 13 to 26 years. The checklist will assess which components of the intervention the provider was able to deliver during the visit.
Measured: 6 months
Provider acceptability of the brief overdose prevention education intervention
Providers in the intervention group will complete 8 questions based on the Theoretical Framework of Acceptability (TFA) acceptability questionnaire on a 5-point Likert scale. The measure will be collected post-intervention training and after all youth have received the intervention
Measured: 6 months
Youth acceptability of the brief overdose prevention education intervention
Youth participants receiving care from providers in the interventions group will be asked after their comprehensive physical exam questions from an investigator developed questionnaire to rate their experience of the visit, receipt of the brief youth overdose prevention education intervention, importance, relevance, and comfort with the information.
Measured: 6 months
Secondary outcomes (4)
Youth perception of risk associated with fentanyl and other emerging drugs
A question assessing "Risk of taking medication you weren't prescribed" on a 3-point Likert scale adapted from the Monitoring the Future (MTF) survey
Measured: Baseline, 2 weeks, 6-months
Youth awareness of strategies to reduce overdose risk
This outcome will be assessed by responses to an investigator developed questionnaire.
Measured: Baseline, 2 weeks, 6-months
Youth's ability to recognize an overdose
This outcome will be assessed by responses to an investigator developed questionnaire.
Measured: Baseline, 2 weeks, 6-months
Youth's ability to respond to an overdose
This outcome will be assessed by responses to an investigator developed questionnaire.
Measured: Baseline, 2 weeks, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start25 Aug 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
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 MSc, Principal investigator, Boston Medical Center, Internal Medicine, Addiction MedicineAmy Yule, MD, Principal investigator, Boston Medical Center, Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022717
- Sponsor's protocol ID
- H-45731
- Other IDs
- R61DA062217
- Status last verified
- Aug 2026
- First submitted
- 6 Jun 2025
- Last updated
- 7 Aug 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Universal Primary Care Based Pilot Intervention to Reduce Youth Overdose Risk
- ClinicalTrials.gov ID
- NCT07022717
- Acronym / sponsor ID
- H-45731
- Conditions
- Overdose
- Keywords
- Brief overdose prevention, Naloxone, Youth patients, Health care providers, Primary care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 15 Jun 2025 (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.
Adolescent (ages 10-19) overdose deaths are the third leading cause of pediatric death and continue to rise in the United States. Healthcare providers have regular and trusted relationships with youth and have experience in providing public health injury prevention counseling. Youth have different motivations for using drugs, and many who experience fatal overdose do not have a history of opioid use. Primary care pediatric providers regularly provide developmentally appropriate injury prevention counseling for leading causes of pediatric fatal and nonfatal injury such as drowning prevention and firearms safety. However, there are no recommended, evidence-based overdose prevention interventions for youth, including in health care settings, even though research supports pediatricians and youth-serving clinicians providing harm reduction strategies such as naloxone distribution and overdose education. Among adults, overdose prevention education reduces overdose, is cost-effective, and can be learned by laypersons. Content commonly includes awareness of fentanyl in the drug supply, risk reduction (e.g., not using alone, risks of polysubstance use), and how to recognize and respond to an overdose, including the use of naloxone.
This study is a pilot two-arm cluster randomized controlled trial (RCT) of a brief overdose prevention education intervention that will be developed in collaboration with the Community Advisory Board (CAB). The primary outcome of this study is to assess the feasibility and acceptability of the brief youth overdose prevention intervention as measured by provider feasibility and acceptability as well as youth acceptability.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Brief youth overdose prevention education, Other: Information about NaloxoneProviders randomized into this arm will complete a 45-minute intervention training. The training will occur either in person or via Zoom teleconference and include overdose prevention education, the pilot brief overdose prevention education intervention, intervention practice, and how to complete the fidelity checklist to be completed at the end of each visit. |
| Control group | Active comparator | Other: Usual standard of careProviders randomized into this arm will deliver usual care to the youth patients. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Physicians and advance practice providers within Pediatric Primary Care and Family Medicine at Boston Medical Center (BMC)
- ≥ 2 clinic sessions per/week
- Ages 13-26
- Scheduled for a comprehensive physical exam with a provider who is participating in the trial
- English speaking
Key exclusion criteria (5 listed)
- None
- 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
- Any medical/psychiatric condition that causes acute distress and requires emergency evaluation
- Under legal custody of the Department of Children and Families (DCF)
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. | Behavioural | Intervention group |
| Information about NaloxoneAlso: NarcanProviders in the intervention group will inform youth participants how to use naloxone and offered a kit to take home. | Other | Intervention group |
| Usual standard of careParticipants will be provided usual care by providers in the control group. | Other | Control group |
Primary outcome
Feasibility of the brief overdose prevention education intervention
Time frame: 6 months
Providers in the intervention arm will complete a checklist after all comprehensive physical exams with youth ages 13 to 26 years. The checklist will assess which components of the intervention the provider was able to deliver during the visit.
Provider acceptability of the brief overdose prevention education intervention
Time frame: 6 months
Providers in the intervention group will complete 8 questions based on the Theoretical Framework of Acceptability (TFA) acceptability questionnaire on a 5-point Likert scale. The measure will be collected post-intervention training and after all youth have received the intervention
Youth acceptability of the brief overdose prevention education intervention
Time frame: 6 months
Youth participants receiving care from providers in the interventions group will be asked after their comprehensive physical exam questions from an investigator developed questionnaire to rate their experience of the visit, receipt of the brief youth overdose prevention education intervention, importance, relevance, and comfort with the information.
4 secondary outcomes
Youth perception of risk associated with fentanyl and other emerging drugs
Time frame: Baseline, 2 weeks, 6-months
Youth awareness of strategies to reduce overdose risk
Time frame: Baseline, 2 weeks, 6-months
Youth's ability to recognize an overdose
Time frame: Baseline, 2 weeks, 6-months
Youth's ability to respond to an overdose
Time frame: Baseline, 2 weeks, 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 7 Aug 2026.
- Individual participant dataSharing planned: No
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Drug-Related Side Effects and Adverse Reaction, Digoxin Overdose
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
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RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
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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.
Sarah Bagley, MD MSc 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 and Information about Naloxone 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 5 inclusion and 5 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 7 Aug 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?
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?
Feasibility of the brief overdose prevention education intervention (time frame: 6 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 7 Aug 2026.