Drug Overdose, Drug Overdose Accidental
Conditions
Brief summary
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
BEHAVIORALBSAFE Intervention
The intervention will include counseling sessions, reminder safety text messages, and linkage to care.
BEHAVIORALAttention control
Attention control (videos)
Sponsors
San Francisco Department of Public Health
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of opioid overdose due to unintentional fentanyl use | 16 months | 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. |
| Incidence of unintentional fentanyl use | 16 months | Incidence of biomarker-confirmed unintentional fentanyl use, as determined by hair sampling for fentanyl and related analogues collected every 4 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported intentional opioid use | 16 months | Self-report of fentanyl use and intentionality utilizing TimeLine Follow Back conducted at visits every 4 months. |
| Fentanyl positive urine | 16 months | Proportion of fentanyl-positive urine drug screen results, as measured at study visits every 4 months. |
| Overdose resulting in Emergency Department presentation | 16 months | Proportion of emergency room presentation for opioid overdose confirmed by electronic health record. |
| Use of overdose prevention strategies | 16 months | Proportion of use of overdose prevention strategies, measured by self-report at each study visit every 4 months. |
Countries
United States
Contacts
CONTACTPhillip O Coffin, MD, MIA
CONTACTXochitl Luna Marti, MPH
PRINCIPAL_INVESTIGATORAlexander Bazazi, MD, PhD
University of California, San Francisco
Outcome results
None listed