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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BSAFE Counseling Intervention | Experimental | 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. |
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| Attention Control | Placebo Comparator | Participants will watch 45 minute videos unrelated to the intervention as an attention control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BSAFE Intervention | Behavioral | The intervention will include counseling sessions, reminder safety text messages, and linkage to care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of opioid overdose due to unintentional fentanyl use | 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. | 16 months |
| Incidence of unintentional fentanyl use | Incidence of biomarker-confirmed unintentional fentanyl use, as determined by hair sampling for fentanyl and related analogues collected every 4 months. | 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported intentional opioid use | Self-report of fentanyl use and intentionality utilizing TimeLine Follow Back conducted at visits every 4 months. | 16 months |
| Fentanyl positive urine | Proportion of fentanyl-positive urine drug screen results, as measured at study visits every 4 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phillip O Coffin, MD, MIA | Contact | (628) 217-6282 | phillip.coffin@sfdph.org | |
| Xochitl Luna Marti, MPH | Contact | (628) 217-6235 | xochitl.lunamarti@sfdph.org |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Bazazi, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Department of Public Health | San Francisco | California | 94102 | United States |
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| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| Attention control | Behavioral | Attention control (videos) |
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| 16 months |
| Overdose resulting in Emergency Department presentation | Proportion of emergency room presentation for opioid overdose confirmed by electronic health record. | 16 months |
| Use of overdose prevention strategies | Proportion of use of overdose prevention strategies, measured by self-report at each study visit every 4 months. | 16 months |
| D001523 | Mental Disorders |