Behavioral Safety and Fentanyl Education: BSAFE

San Francisco Department of Public Health

Status: Not yet enrolling

Conditions: Drug Overdose Accidental; Drug Overdose

Treatments: Behavioral: BSAFE Intervention; Behavioral: Attention control

Study type: Interventional

Funder types: Other

Identifiers

NCT07219082

1R01DA064340-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Aged 18 years or older,
2. Reports intentional cocaine or methamphetamine use >15 of past 30 days,
3. Urine positive for cocaine or methamphetamine and negative for opioids/fentanyl prior to enrollment
4. Be able to provide the names of at least 2 persons who can consistently locate their whereabouts.

Exclusion criteria

1. Reports past 30-day intentional use of any opioid or ongoing use of an opioid antagonist (e.g., naltrexone)
2. Intends to leave area in coming year,
3. Unable to communicate in English or Spanish,
4. Any other condition that, in the PI's judgment, interferes with safe study participation or adherence to study procedures.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups, including a placebo group

BSAFE Counseling Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: BSAFE Intervention

Attention Control

Placebo Comparator group

Description:

Participants will watch 45 minute videos unrelated to the intervention as an attention control.

Treatment:

Behavioral: Attention control