Behavioral Safety and Fentanyl Education: BSAFE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Incidence of opioid overdose due to unintentional fentanyl use
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older,
- •Reports intentional cocaine or methamphetamine use ≥7 of past 30 days,
- •Urine positive for cocaine or methamphetamine and negative for opioids/fentanyl prior to enrollment
- •Be able to provide the names of at least 2 persons who can consistently locate their whereabouts.
- •Reports at least one suspected unintentional fentanyl use event, including unexpected sedation or unexpected fentanyl-positive bodily fluid drug testing result.
排除标准
- •Reports past 30-day intentional use of any opioid or ongoing use of an opioid antagonist (e.g., naltrexone)
- •Intends to leave area in coming year,
- •Unable to communicate in English or Spanish,
- •Any other condition that, in the PI's judgment, interferes with safe study participation or adherence to study procedures.
研究组 & 干预措施
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.
干预措施: BSAFE Intervention (Behavioral)
Attention Control
Participants will watch 45 minute videos unrelated to the intervention as an attention control.
干预措施: Attention control (Behavioral)
结局指标
主要结局
Incidence of opioid overdose due to unintentional fentanyl use
时间窗: 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 opioid overdose due to unintentional fentanyl use
时间窗: 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.
次要结局
未报告次要终点
研究者
Phillip Coffin, MD, MIA
Director, Substance Use Research
San Francisco Department of Public Health