Overdose Prevention Education for Youth

Overseen By Sarah Bagley, MD MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Cognitive limitation, Acute distress, DCF custody, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a brief education program in preventing drug overdoses among young people. It focuses on teaching youth about the risks of drugs, such as fentanyl, and how to safely respond to an overdose, including the use of naloxone, a medication that can reverse overdoses. The trial includes two groups: one receives this specialized education, while the other receives regular care. Youth aged 13-26 who are scheduled for a physical exam and can speak English may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to important educational research that could save lives.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial organizers or your healthcare provider.

What prior data suggests that this overdose prevention education is safe for youth?

Studies have shown that teaching people how to prevent overdoses is generally safe. This training helps individuals understand opioid overdoses and how to use naloxone, a medication that can reverse them. Although the training doesn't involve taking any medication, it provides knowledge that can potentially save lives. Research has demonstrated that this education is effective in adults and doesn't cause harm. Now, researchers are adapting it for young people. This pilot study examines how well young people and their healthcare providers accept this training. No reports indicate any negative effects from receiving this kind of education. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the brief youth overdose prevention education because it offers a proactive approach to tackling overdose risks among young people. Unlike traditional methods that often focus on treatment after an overdose has occurred, this intervention emphasizes prevention through education, aiming to equip youth with vital knowledge and skills before an incident happens. The program's flexibility, allowing for in-person or Zoom-based training, makes it accessible and adaptable to different settings, potentially reaching a wider audience. This proactive and educational approach could significantly reduce overdose incidents, making it a promising new tool in overdose prevention efforts.

What evidence suggests that this trial's brief youth overdose prevention education could be effective?

Research shows that teaching people about preventing overdoses enhances their understanding of opioid overdoses and the use of naloxone, a life-saving medicine during an overdose. Studies have found that these educational programs improve awareness and understanding of the risks associated with opioid use and overdoses. For adults, these programs have lowered overdose deaths and are cost-effective. In this trial, the intervention group will receive a 45-minute training session focused on overdose prevention education, while the control group will receive usual care. Although direct evidence for young people is still being gathered, researchers expect these methods to help reduce overdoses among them. The goal is to make young people aware of overdose risks and teach them how to respond safely. ^{2 6 7 8 9}

Who Is on the Research Team?

Sarah Bagley, MD MSc

Principal Investigator

Boston Medical Center, Internal Medicine, Addiction Medicine

Amy Yule, MD

Principal Investigator

Boston Medical Center, Psychiatry

Are You a Good Fit for This Trial?

This trial is for adolescents aged 10-19 in the United States who may benefit from overdose prevention education. The study aims to assess a new intervention's feasibility and acceptability among youth and healthcare providers.

Inclusion Criteria

Physicians and advance practice providers within Pediatric Primary Care and Family Medicine at Boston Medical Center (BMC) with ≥ 2 clinic sessions per week

I am between 13-26 years old and have a physical exam scheduled with a trial-participating provider. I speak English.

Exclusion Criteria

My provider thinks my cognitive condition prevents me from joining.

I am a caregiver of a youth (13-17) who cannot consent or doesn't speak English.

I am a young person in need of urgent care for a mental or physical health crisis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Training

Providers in the intervention group complete a 45-minute training session on overdose prevention education, either in person or via Zoom.

1 session

1 visit (in-person or virtual)

Intervention Implementation

Providers deliver the brief overdose prevention education intervention to youth patients during comprehensive physical exams.

6 months

Follow-up

Participants are monitored for feasibility and acceptability of the intervention, with assessments at baseline, 2 weeks, and 6 months.

6 months

Multiple assessments (baseline, 2 weeks, 6 months)

What Are the Treatments Tested in This Trial?

Interventions

• Brief youth overdose prevention education

Trial Overview The trial tests a brief educational program on overdose prevention, including naloxone information, against usual standard care. It's a pilot randomized controlled trial with two groups: one receiving the intervention and the other continuing with regular advice.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 2 Interventions

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.

Group II: Control group Active Control 1 Intervention

Providers randomized into this arm will deliver usual care to the youth patients.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3864124/

Brief overdose education can significantly increase ... The data indicate that overdose prevention training improves participants' knowledge of opioid overdose and naloxone use.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0306460325000231

Effectiveness of educational interventions in United States ... Four studies showed improved knowledge and attitudes towards opioid use and two showed increased understanding of opioid withdrawal and overdose ...

3. journals.lww.com journals.lww.com/journaladdictionmedicine/fulltext/9900/a_scoping_review_of_youth_overdose_prevention.503.aspx

A Scoping Review of Youth Overdose Prevention We identified a total of 16 unique programs that fit our inclusion criteria, 9 from the peer-reviewed literature and 7 from the gray literature.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40344021/

A Scoping Review of Youth Overdose Prevention ... The 2 key objectives of this study were (1) to identify and summarize existing youth overdose prevention interventions and (2) to delineate what ...

5. ajph.aphapublications.org ajph.aphapublications.org/doi/10.2105/AJPH.2024.307849

The Call for a School-Based Approach to Opioid Overdose ... Overdose education with naloxone distribution (OEND) is a proven public health strategy that reduces opioid overdose deaths in adults and may be ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11571193/

Preventing Substance Use and Overdose Among Young ... The reality is that substance use in the United States has never been riskier, whether it is done by adolescents or young adults engaging in ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955395913000807

Brief overdose education can significantly increase ... Conclusions. The data indicate that overdose prevention training improves participants' knowledge of opioid overdose and naloxone use, but naloxone may be ...

8. naco.org naco.org/resource/osc-youth-prevention

Youth-Focused Prevention: A NACo Opioid Solutions ... Youth-focused programs can help counties achieve a variety of goals, including reducing the number of youth who begin using substances.

9. kff.org kff.org/mental-health/teens-drugs-and-overdose-contrasting-pre-pandemic-and-current-trends/

Teens, Drugs, and Overdose: Contrasting Pre-Pandemic ... Fentanyl deaths as a share of all adolescent drug overdose deaths increased significantly from 32% in 2018 to 65% in 2020. This increase marked ...