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NCT Number: NCT07219082

Behavioral Safety and Fentanyl Education: BSAFE

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.

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Key information

Conditions

Drug Overdose Chemically-Induced Disorders Drug Misuse Drug Overdose Accidental Mental Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Department of Public Health

San Francisco, California, 94102, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Treatment and study plan

BSAFE Intervention

Behavioral

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

Attention Control

Behavioral

Attention control (videos)

Primary outcomes

  1. 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.

  2. Incidence of unintentional fentanyl use

    Time frame: 16 months

    Incidence of biomarker-confirmed unintentional fentanyl use, as determined by hair sampling for fentanyl and related analogues collected every 4 months.

Secondary outcomes

  1. Self-reported intentional opioid use

    Time frame: 16 months

    Self-report of fentanyl use and intentionality utilizing TimeLine Follow Back conducted at visits every 4 months.

  2. Fentanyl positive urine

    Time frame: 16 months

    Proportion of fentanyl-positive urine drug screen results, as measured at study visits every 4 months.

  3. Overdose resulting in Emergency Department presentation

    Time frame: 16 months

    Proportion of emergency room presentation for opioid overdose confirmed by electronic health record.

  4. Use of overdose prevention strategies

    Time frame: 16 months

    Proportion of use of overdose prevention strategies, measured by self-report at each study visit every 4 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Phillip O Coffin, MD, MIA

CONTACT

[email protected]

(628) 217-6282

Xochitl Luna Marti, MPH

CONTACT

[email protected]

(628) 217-6235

Sponsors and collaborators

Lead sponsor

San Francisco Department of Public Health

Other Gov

Collaborators

  • University of California, San Francisco

Registry information

Acronym: BSAFE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Oct 21, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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