Behavioral Safety and Fentanyl Education: BSAFE

NCT07219082 | Not Yet Recruiting DMC

• 1 other identifier: 1R01DA064340-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Overdose; Drug Overdose Accidental

Outcome Measures

Primary Outcomes (1)

• Incidence of opioid overdose due to unintentional fentanyl use

  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.

  16 months

Study Arms (2)

BSAFE Counseling Intervention

EXPERIMENTAL

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.

Behavioral: BSAFE Intervention

Attention Control

PLACEBO COMPARATOR

Participants will watch 45 minute videos unrelated to the intervention as an attention control.

Behavioral: Attention control

Interventions

BSAFE Intervention BEHAVIORAL

The intervention will include counseling sessions, reminder safety text messages, and linkage to care.

BSAFE Counseling Intervention

Attention control BEHAVIORAL

Attention control (videos)

Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older,
• Reports intentional cocaine or methamphetamine use \>15 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Francisco Department of Public Health: lead

Study Sites (1)

San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Phillip O Coffin, MD, MIA

  San Francisco Department of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phillip O Coffin, MD, MIA

CONTACT

(628) 217-6282; phillip.coffin@sfdph.org

Xochitl Luna Marti, MPH

CONTACT

(628) 217-6235; xochitl.lunamarti@sfdph.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Substance Use Research

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: October 21, 2025
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): January 15, 2030
• Study Completion (Estimated): January 15, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)