Fentanyl Education for Drug Overdose
(BSAFE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a counseling program can help individuals who use stimulants, such as cocaine or meth, reduce their risk of accidental fentanyl overdose. Participants will either receive the BSAFE counseling intervention, which includes personalized plans and weekly reminders, or watch unrelated videos for comparison (attention control). The trial targets individuals who regularly use stimulants and have not recently used opioids. The study focuses on reducing overdose risk through education and behavior change. As an unphased trial, it offers participants the opportunity to contribute to important research that could lead to new strategies for overdose prevention.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used opioids in the past 30 days or are using an opioid blocker like naltrexone.
What prior data suggests that this intervention is safe for reducing overdose risk behaviors?
Research has shown that the BSAFE program is designed to be safe and supportive. It employs motivational interviewing, a counseling technique that encourages positive changes without judgment. This method is generally easy to manage and lacks the side effects associated with medications.
The program also incorporates text message reminders and assistance in finding care for stimulant use. These components emphasize education and support over medication, reducing the likelihood of negative side effects.
Although details about the study phase are not provided, the focus on behavioral support suggests minimal risk for participants. This makes the program a safe option for those aiming to reduce their risk of overdose.12345Why are researchers excited about this trial?
Researchers are excited about the BSAFE Intervention because it offers a personalized approach to reducing overdose risk, which is different from traditional methods that often rely on medication or broad educational programs. BSAFE uses motivational interviewing to create tailored plans for individuals, aiming to change personal risk behaviors directly. Additionally, it incorporates weekly safety reminders via text messages and connects participants to care for managing stimulant use, offering a comprehensive support system that current treatments may lack. This multifaceted approach could provide a more effective and engaging way to prevent overdoses.
What evidence suggests that this trial's interventions could be effective for reducing overdose and risk behaviors?
In this trial, participants may receive the BSAFE program, designed to reduce overdoses and risky behaviors in people who use stimulants and might accidentally use fentanyl. The program builds on successful strategies for preventing opioid overdoses, which have been proven to lower overdose risks. It incorporates motivational interviewing, a counseling method that helps people make changes, and skills-building techniques to create personal safety plans. Studies have shown that similar programs can effectively reduce overdose chances by educating people and connecting them to care. The goal is to provide practical tools and support to manage stimulant use and avoid accidental fentanyl exposure. Another group in this trial will receive an attention control, where participants will watch 45-minute videos unrelated to the intervention.12467
Who Is on the Research Team?
Phillip O Coffin, MD, MIA
Principal Investigator
San Francisco Department of Public Health
Are You a Good Fit for This Trial?
The BSAFE trial is for individuals who use stimulants and may unintentionally use fentanyl, aiming to reduce overdose and risky behaviors. Specific eligibility criteria are not provided, but typically include factors like age, health status, and substance use patterns.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the BSAFE intervention, including motivational interviewing-based counseling, weekly text message safety reminders, and linkage to care for managing stimulant use
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Attention control
- BSAFE Intervention
Trial Overview
BSAFE tests a brief intervention based on an Informational-Motivation-Behavior (IMB) model against an attention-control group. It incorporates established overdose education to see if it can effectively lower the risk of overdose among participants.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The BSAFE intervention will consist of three elements: motivational interviewing-based Counseling focused on a personalized plan to reduce risk for UFU and resultant overdose, (2) weekly text message Safety Reminders, and (3) Linkage to Care for managing stimulant use. The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors.
Participants will watch 45 minute videos unrelated to the intervention as an attention control.
Find a Clinic Near You
Who Is Running the Clinical Trial?
San Francisco Department of Public Health
Lead Sponsor
Citations
Behavioral Safety and Fentanyl Education: BSAFE
Study Overview. Brief Summary. BSAFE is a randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among ...
Overdose Prevention Strategy
Rx opioid overdose deaths increased 4.1-fold. Heroin overdose deaths increased 2.5-fold. *This graph shows the total number of drug overdose deaths in the ...
Behavioral Safety and Fentanyl Education - NIH RePORTER
We propose to adapt a successful opioid overdose prevention intervention to address UFU among people who use stimulants and do not intentionally use opioids and ...
OD2A Case Study: Harm Reduction | Overdose Prevention
Read about how harm reduction works to reduce drug overdose from a case study from Overdose Data to Action in Illinois.
5.
library.samhsa.gov
library.samhsa.gov/sites/default/files/overdose-prevention-response-kit-pep23-03-00-001.pdfSAMHSA Overdose Prevention and Response Toolkit
1 In addition, provisional data from CDC now show that overdose deaths have declined throughout 2024, with a projected decline of nearly 27% in ...
Overdose Prevention and Response Toolkit
SAMHSA's updated Overdose Prevention and Response Toolkit provides guidance to a wide range of individuals on preventing and responding to an overdose.
The Overdose Response Strategy: Reducing Drug ...
The Overdose Response Strategy serves as a strategic partnership model that can potentially be applied to other issues, such as gun violence, that may benefit ...
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