Menu
Not yet recruiting NCT07219082

Behavioral Safety and Fentanyl Education: BSAFE

No phase Interventional Drug Overdose Drug Overdose Accidental

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BSAFE Intervention, Attention control.
Who it may be relevant to
Registry conditions: Drug Overdose, Drug Overdose Accidental. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral BSAFE Intervention
    The intervention will include counseling sessions, reminder safety text messages, and linkage to care.
  • Behavioral Attention control
    Attention control (videos)

Primary outcome measures

  • Incidence of opioid overdose due to unintentional fentanyl use [Time frame: 16 months]
  • Incidence of unintentional fentanyl use [Time frame: 16 months]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • San Francisco Department of Public Health — San Francisco

Identifiers

NCT: NCT07219082 · 1R01DA064340-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗