Recruiting

BSAFE vs. Attention-Control

Sponsor:

San Francisco Department of Public Health

Code:

NCT07219082

Conditions

Drug Overdose

Drug Overdose Accidental

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

BSAFE Intervention

Attention control

Study Details

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

Study ID

NCT07219082

Start date

Aug 11, 2026

Status verified date

Aug, 2026

Completion date

Jan 15, 2030

Anticipated

Primary completion date

Jan 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Aged 18 years or older,
2. Reports intentional cocaine or methamphetamine use ≥7 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.
5. Reports at least one suspected unintentional fentanyl use event, including unexpected sedation or unexpected fentanyl-positive bodily fluid drug testing result.

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

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

BSAFE Intervention

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

Attention control

Attention control (videos)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Phillip O Coffin, MD, MIA

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

Xochitl Luna Marti, MPH

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

Locations

San Francisco Department of Public Health

Recruiting

San Francisco, California, United States, 94102

Contacts

Phillip Coffin, MD

628-217-6282phillip.coffin@sfdph.org

More Information

Sponsor

San Francisco Department of Public Health

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by San Francisco Department of Public Health on 2026-08-18.