Health TrialsbyHealthPanel

Behavioral Safety and Fentanyl Education: BSAFE

ConditionsDrug OverdoseDrug Overdose Accidental
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSan Francisco Department of Public Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • BSAFE Intervention

    Behavioral

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

  • Attention control

    Behavioral

    Attention control (videos)

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: BSAFE Counseling InterventionExperimental treatment 1 intervention
Group B: Attention ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

Fentanyl positive urine

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

Time frame
16 months
3

Overdose resulting in Emergency Department presentation

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

Time frame
16 months
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

San Francisco Department of Public Health

Lead sponsor

University of California, San Francisco

Collaborator

Source ClinicalTrials.gov
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