Behavioral Safety and Fentanyl Education: BSAFE

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Aged 18 years or older, 2. Reports intentional cocaine or methamphetamine use ≥7 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. 5. Reports at least one suspected unintentional fentanyl use event, including unexpected sedation or unexpected fentanyl-positive bodily fluid drug testing result.

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Behavioral: BSAFE Intervention
    The intervention will include counseling sessions, reminder safety text messages, and linkage to care.
Placebo Comparator
Attention Control 		Participants will watch 45 minute videos unrelated to the intervention as an attention control.
  • Behavioral: Attention control
    Attention control (videos)

Recruiting Locations

San Francisco Department of Public Health
San Francisco, California 94102
Contact:
Phillip Coffin, MD
628-217-6282
phillip.coffin@sfdph.org

More Details

Status
Recruiting
Sponsor
San Francisco Department of Public Health

Study Contact

Phillip O Coffin, MD, MIA
(628) 217-6282
phillip.coffin@sfdph.org