Behavioral Safety and Fentanyl Education: BSAFE
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Incidence of opioid overdose due to unintentional fentanyl use
Study Overview
Brief Summary
BSAFE is a randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among people who use stimulants who may have unintentional fentanyl use (UFU). It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the efficacy of BSAFE vs attention-control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 18 years or older,
- •Reports intentional cocaine or methamphetamine use ≥7 of past 30 days,
- •Urine positive for cocaine or methamphetamine and negative for opioids/fentanyl prior to enrollment
- •Be able to provide the names of at least 2 persons who can consistently locate their whereabouts.
- •Reports at least one suspected unintentional fentanyl use event, including unexpected sedation or unexpected fentanyl-positive bodily fluid drug testing result.
Exclusion Criteria
- •Reports past 30-day intentional use of any opioid or ongoing use of an opioid antagonist (e.g., naltrexone)
- •Intends to leave area in coming year,
- •Unable to communicate in English or Spanish,
- •Any other condition that, in the PI's judgment, interferes with safe study participation or adherence to study procedures.
Arms & Interventions
BSAFE Counseling Intervention
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.
Intervention: BSAFE Intervention (Behavioral)
Attention Control
Participants will watch 45 minute videos unrelated to the intervention as an attention control.
Intervention: Attention control (Behavioral)
Outcomes
Primary Outcomes
Incidence of opioid overdose due to unintentional fentanyl use
Time Frame: 16 months
Incidence of overdose will be measured by a composite measure of non-fatal and fatal overdose count collected by blinded assessors from Timeline Follow-Back (TLFB) every 4 months and vital record linkage for overdose fatalities.
Incidence of opioid overdose due to unintentional fentanyl use
Time Frame: 16 months
Incidence of overdose will be measured by a composite measure of non-fatal and fatal overdose count collected by blinded assessors from Timeline Follow-Back (TLFB) every 4 months and vital record linkage for overdose fatalities.
Secondary Outcomes
No secondary outcomes reported
Investigators
Phillip Coffin, MD, MIA
Director, Substance Use Research
San Francisco Department of Public Health