Behavioral Safety and Fentanyl Education: BSAFE

Part of paid clinical trials in San Francisco, California.

Sponsor
San Francisco Department of Public Health
Study ID
NCT07219082
Status
Recruiting
Apply to this trial

Conditions

  • Drug Overdose
  • Drug Overdose Accidental

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • BSAFE Intervention — BEHAVIORAL
    The intervention will include counseling sessions, reminder safety text messages, and linkage to care.
  • Attention control — BEHAVIORAL
    Attention control (videos)

Study Details

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.

Key Dates

First listed
Oct 21, 2025
Start date
Aug 11, 2026
Status verified
Aug 2026
Primary completion
Jan 15, 2030
Completion
Jan 15, 2030

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • Placebo Comparator: Attention Control
    Participants will watch 45 minute videos unrelated to the intervention as an attention control.

Primary Outcome Measure

Incidence of opioid overdose due to unintentional fentanyl use [ Time Frame: 16 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco Department of Public HealthSan FranciscoCalifornia94102
Phillip Coffin, MD
[email protected]
628-217-6282

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By research site
San Francisco Department of Public Health· San Francisco, CA

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