Behavioral Safety and Fentanyl Education: BSAFE

NCT ID: NCT07219082

Last Updated: 2025-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2030-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Drug Overdose Drug Overdose Accidental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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BSAFE Counseling Intervention

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.

Group Type EXPERIMENTAL

BSAFE Intervention

Intervention Type BEHAVIORAL

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

Attention Control

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

Group Type PLACEBO_COMPARATOR

Attention control

Intervention Type BEHAVIORAL

Attention control (videos)

Interventions

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BSAFE Intervention

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

Intervention Type BEHAVIORAL

Attention control

Attention control (videos)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Francisco Department of Public Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Phillip Coffin, MD, MIA

Director, Substance Use Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Phillip O Coffin, MD, MIA

Role: PRINCIPAL_INVESTIGATOR

San Francisco Department of Public Health

Locations

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San Francisco Department of Public Health

San Francisco, California, United States

Site Status

Countries

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United States

Central Contacts

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Phillip O Coffin, MD, MIA

Role: CONTACT

(628) 217-6282

Xochitl Luna Marti, MPH

Role: CONTACT

(628) 217-6235

Other Identifiers

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1R01DA064340-01

Identifier Type: NIH

Identifier Source: org_study_id

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