An interventional study of BSAFE Intervention and Attention control in Drug Overdose and Drug Overdose Accidental, sponsored by San Francisco Department of Public Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by San Francisco Department of Public Health · Not applicable, Interventional, and Prevention
Among 72 studies in Drug Overdose with a site in United States — 17 open to participants now, 28 under way, none of them phase 3. Drug Overdose · United States.
Among the 72 studies in Drug Overdose with a site in United States, this one is the 30th largest by planned enrollment of the 58 interventional ones, is one of 7 that started in 2026, is one of 51 with no phase, reaches primary completion later than 25 of the 27 other live ones, and was the 66th registered.
104 studies on the registry are indexed under Drug Overdose; 22 are open to participants now.
This study's planned enrollment of 160 is above the median of 124 across 76 interventional studies indexed under Drug Overdose.
Browse Drug Overdose studies →17 of the 72 studies in Drug Overdose with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 13 Drug Overdose studies recruiting now, 12 (92%) set no upper age limit and 1 (8%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →72 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 7 started in 2026.
Median enrollment 182 across the 58 interventional studies, 217 across the 14 observational. Of the 40 that completed or were terminated, 18 (45%) have results posted.
2 of 72 have an industry lead sponsor. The 10 most frequent:
San Francisco Department of Public Health is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
San Francisco Department of Public Health has 3 studies filed under Drug Overdose — fewer than ten, so there is no comparison to draw.
8 of the studies in Drug Overdose with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07022717Boston Medical CenterA Universal Primary Care Based Intervention to Reduce Youth Overdose Risk | 2026-11 |
| NCT05320835Johns Hopkins Bloomberg School of Public HealthA Setting Focus Overdose Prevention Intervention | 2026-12-01 |
| NCT06236087NYU Langone HealthOverdose Prevention Centers and Behavioral Health | 2026-12-31 |
| NCT07170072NYU Langone HealthShelter HArm Reduction Evaluation | 2027-03-31 |
| NCT05657106April M YoungKentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk | 2027-05-31 |
Among the 72 studies in Drug Overdose with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Participants will watch 45 minute videos unrelated to the intervention as an attention control.
Behavioral: Attention control
The intervention will include counseling sessions, reminder safety text messages, and linkage to care.
Attention control (videos)
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.
Time frame: 16 months
Incidence of unintentional fentanyl use
Incidence of biomarker-confirmed unintentional fentanyl use, as determined by hair sampling for fentanyl and related analogues collected every 4 months.
Time frame: 16 months
Self-reported intentional opioid use
Self-report of fentanyl use and intentionality utilizing TimeLine Follow Back conducted at visits every 4 months.
Time frame: 16 months
Fentanyl positive urine
Proportion of fentanyl-positive urine drug screen results, as measured at study visits every 4 months.
Time frame: 16 months
Overdose resulting in Emergency Department presentation
Proportion of emergency room presentation for opioid overdose confirmed by electronic health record.
Time frame: 16 months
Use of overdose prevention strategies
Proportion of use of overdose prevention strategies, measured by self-report at each study visit every 4 months.
Time frame: 16 months
Started Aug 2026 (actual). Primary completion is estimated for Jan 2030, 41 months after the start.
Of 47 non-industry interventional studies with no phase under Drug Overdose, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 49. This study's planned 41 months is above that.
Counting every sponsor, half of 47 studies reached it within 31 months; a quarter within 13 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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San Francisco Department of Public Health