An interventional study of Brief youth overdose prevention education and Usual Standard of Care in Overdose, sponsored by Boston Medical Center. Recruiting at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Prevention
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. Twenty-four providers and 624 youth patient participants randomized (at the provider level) will be enrolled to receive either the brief overdose prevention intervention or usual care will be enrolled.
104 studies on the registry are indexed under Drug Overdose; 22 are open to participants now.
This study's planned enrollment of 648 is above the median of 124 across 76 interventional studies indexed under Drug Overdose.
Browse Drug Overdose studies →Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 10, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Providers:
Youth:
Exclusion Criteria:
Providers:
Youth:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Providers randomized to the intervention group will complete two 30-minute trainings in person or 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.
Behavioral: Brief youth overdose prevention education
Providers randomized to the control group will provide usual care to youth during comprehensive physical exam (CPE) or follow-up clinical appointments.
Other: Usual Standard of Care
Providers in the intervention group will inform youth participants about: the risk factors for overdose, how to recognize an overdose, and how to respond to an overdose. Providers in the intervention group will also educate youth participants on naloxone use and provide assistance with accessing naloxone.
Youth participants will be provided usual care by providers in the control group. As part of usual care, providers may educate youth participants on naloxone use and provide assistance with accessing naloxone.
Youth knowledge of risk associated with exposure to fentanyl and other emerging drugs
Assessed using a 4-point Likert-scale question adapted from the Monitoring the Future (MTF) survey measuring perceived risk of harm from taking prescription medication that was not prescribed or taking medication other than prescribed. Possible scores range from 1 (no risk) to 4 (great risk), with higher scores indicating greater perceived risk of harm (a better outcome).
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Youth knowledge of strategies to reduce overdose risk
Assessed using 4-point Likert-scale questions adapted from the Monitoring the Future (MTF) survey measuring perceived risk associated with using more than one substance at a time and using substances while alone. Possible scores range from 1 (no risk) to 4 (great risk), with higher scores indicating greater perceived risk of harm (a better outcome).
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Youth's ability to recognize an overdose
Assessed using questions adapted from the Opioid Overdose Knowledge Scale (OOKS) evaluating participants' ability to identify signs of an opioid overdose.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Youth's ability to respond to an overdose
Assessed using a question adapted from the Opioid Overdose Knowledge Scale (OOKS) evaluating participants' knowledge of steps in opioid overdose response.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.