Behavioral Safety and Fentanyl Education: BSAFE

Not Applicable

Not yet recruiting

• Conditions: Drug Overdose; Drug Overdose Accidental

• Registration Number: NCT07219082
• Lead Sponsor: San Francisco Department of Public Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-17
• Study First Submitted QC: 2025-10-17
• Last Update Submitted: 2025-10-20
• Study First Posted: 2025-10-21
• Last Update Posted: 2025-10-22
• Study Start: 2025-12-15
• Primary Completion: 2030-01-15
• Study Completion: 2030-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Aged 18 years or older,
2. Reports intentional cocaine or methamphetamine use >15 of past 30 days,
3. Urine positive for cocaine or methamphetamine and negative for opioids/fentanyl prior to enrollment
4. Be able to provide the names of at least 2 persons who can consistently locate their whereabouts.

Exclusion Criteria

1. Reports past 30-day intentional use of any opioid or ongoing use of an opioid antagonist (e.g., naltrexone)
2. Intends to leave area in coming year,
3. Unable to communicate in English or Spanish,
4. Any other condition that, in the PI's judgment, interferes with safe study participation or adherence to study procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of opioid overdose due to unintentional fentanyl use	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.

Trial Locations

Locations (1)

San Francisco Department of Public Health; 🇺🇸 San Francisco, California, United States