Drug OverdoseBSAFENCT07219082
Behavioral Safety and Fentanyl Education: BSAFE
A study testing BSAFE Intervention in people with Drug Overdose and Drug Overdose Accidental, run by San Francisco Department of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Overdose, Drug Overdose Accidental
- What is being tested?
- BSAFE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2026to 15 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older,
- Reports intentional cocaine or methamphetamine use ≥7 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Francisco Department of Public Health
San Francisco, California, 94102
Phillip Coffin, MD, 628-217-6282, phillip.coffin@sfdph.org
About this study
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
- Being tested
- BSAFE Intervention, Attention control
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSAFE InterventionBehavioural
The intervention will include counseling sessions, reminder safety text messages, and linkage to care.
Attention controlBehavioural
Attention control (videos)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: BSAFE Intervention |
| Attention Control | Placebo comparator | Participants will watch 45 minute videos unrelated to the intervention as an attention control. Receives: Behavioral: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 months
Secondary outcomes (4)
Self-reported intentional opioid use
Self-report of fentanyl use and intentionality utilizing TimeLine Follow Back conducted at visits every 4 months.
Measured: 16 months
Fentanyl positive urine
Proportion of fentanyl-positive urine drug screen results, as measured at study visits every 4 months.
Measured: 16 months
Overdose resulting in Emergency Department presentation
Proportion of emergency room presentation for opioid overdose confirmed by electronic health record.
Measured: 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.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start11 Aug 2026
- Primary completion15 Jan 2030 (estimated)
- Study completion15 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Francisco Department of Public Health
- Sponsor type
- Other government
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Phillip Coffin, MD, MIA, San Francisco Department of Public Health
- Investigators
- Alexander Bazazi, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219082
- Sponsor's protocol ID
- 1R01DA064340-01
- Acronym
- BSAFE
- Status last verified
- Aug 2026
- First submitted
- 17 Oct 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Safety and Fentanyl Education: BSAFE
- ClinicalTrials.gov ID
- NCT07219082
- Acronym / sponsor ID
- BSAFE / 1R01DA064340-01
- Conditions
- Drug Overdose, Drug Overdose Accidental
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- San Francisco Department of Public HealthOther government
- Collaborators
- University of California, San Francisco
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 15 Jan 2030 (estimated)
- Study completion
- 15 Jan 2030 (estimated)
- First posted
- 21 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BSAFE Counseling Intervention | Experimental | Behavioral: BSAFE InterventionThe 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. |
| Attention Control | Placebo comparator | Behavioral: Attention controlParticipants will watch 45 minute videos unrelated to the intervention as an attention control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older,
- Reports intentional cocaine or methamphetamine use ≥7 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BSAFE InterventionThe intervention will include counseling sessions, reminder safety text messages, and linkage to care. | Behavioural | BSAFE Counseling Intervention |
| Attention controlAttention control (videos) | Behavioural | Attention Control |
Primary outcome
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.
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.
4 secondary outcomes
Self-reported intentional opioid use
Time frame: 16 months
Fentanyl positive urine
Time frame: 16 months
Overdose resulting in Emergency Department presentation
Time frame: 16 months
Use of overdose prevention strategies
Time frame: 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Bazazi, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BSAFE Intervention in people with Drug Overdose and Drug Overdose Accidental, run by San Francisco Department of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phillip O Coffin, MD, MIA ((628) 217-6282, phillip.coffin@sfdph.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of opioid overdose due to unintentional fentanyl use (time frame: 16 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.