Behavioral safety and fentanyl education: bsafe - fentanyl overdose mortality has skyrocketed over the past decade

The National Institute on Drug Abuse awarded Public Health Foundation Enterprises, Inc. (doing business as Heluna Health) $3.122 million on September 30, 2025, under the Drug Use and Addiction Research Programs (CFDA 93.279) to conduct a randomized-controlled trial of B-SAFE, a behavioral intervention addressing unintentional fentanyl use among stimulant users who do not intentionally use opioids.

The B-SAFE intervention adapts a successful opioid overdose prevention program to focus on reducing fentanyl contamination risk through behavioral and educational strategies targeting how drugs are obtained, prepared, and consumed. The study will enroll 160 participants in San Francisco over a 16-month enrollment period, with follow-up visits every four months, and will test B-SAFE—which includes individualized prevention planning, weekly SMS reminders, and linkage to stimulant use treatment—against usual care controls including referrals to low-threshold services and on-site overdose prevention supplies.

The City and County of San Francisco Department of Public Health, through Principal Investigator Dr. Phillip Coffin, serves as the clinical and operational host for the trial, with Dr. Coffin dedicating 1.2 person-months annually to overall scientific direction, regulatory compliance, staff supervision, adverse event oversight, and clinical leadership. The Regents of the University of California, San Francisco participates as a Multiple Principal Investigator institution, with Dr. ShParam Bazazi jointly overseeing study design and development, intervention adaptation, recruitment, data management, and analyses, while Co-Investigators Dr. McCuistian and Dr. Glidden contribute expertise in cultural adaptation of behavioral interventions and data analysis, respectively.

Performance occurs in San Francisco, California. The award period runs through May 31, 2030.

Most of these deaths also involve stimulants (cocaine or methamphetamine). Multiple investigations have demonstrated a substantial contribution of unintentional fentanyl use (UFU) to medically-attended opioid overdose and opioid overdose mortality. This mostly occurs among people using stimulants (cocaine or methamphetamine). While contamination of drugs contributes to UFU, the mechanism is usually related to how drugs are obtained, prepared, and consumed (e.g., finding a drug that is assumed to be a stimulant, letting someone else prepare a drug for use, or using a pipe that was used by someone else). This mechanism of risk can be readily intervened upon with behavioral and educational strategies. We propose to adapt a successful opioid overdose prevention intervention to address UFU among people who use stimulants and do not intentionally use opioids and adapt that intervention to ensure acceptability among high-risk persons. The repeated-dose intervention, b-safe, will focus on developing an individualized UFU prevention plan, augmented with weekly SMS reminders and linkage to care for stimulant use treatment. We will test the intervention against usual care (referrals to low-threshold services and treatment, on-site access to overdose prevention supplies) with attention control in a randomized-controlled trial of 160 persons seen every 4 months over 16 months. Results from this trial, conducted at the SAN francisco department of public health, will allow US to evaluate a critical intervention to reduce fentanyl overdose and resultant death among a population that should not be experiencing opioid overdose at all. If the intervention proves effective, the health department is well-positioned to continue providing the service.