Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Feasibility of a randomized trial with REBOOT
研究概览
简要总结
REBOOT is a pilot randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients (REBOOT). It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the feasibility of an efficacy trial of REBOOT vs treatment as usual (information and referrals) that will evaluate overdose events (non-fatal or death), drug use cessation, and overdose and HIV risk behaviors, among opioid-dependent persons who have previously overdosed and already received take-home naloxone (the opioid antagonist used to reverse overdose).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-65 years;
- •current opioid dependence by SCID
- •urine positive for opioids during screening, excluding prescribed agonist maintenance therapy
- •history of prior opioid overdose
- •previously received take-home naloxone
- •no serious illnesses likely to progress clinically during trial
- •able and willing to provide informed consent, provide locator information, communicate in English, adhere to visit schedule
排除标准
- •suicidal ideation by concise health risk tracking (CHRT)
- •currently participating in another interventional research study that could possible impact the study's outcomes of interest
- •any condition that, in the Principal Investigator's judgment, interferes with safe study participation or adherence to study procedures
结局指标
主要结局
Feasibility of a randomized trial with REBOOT
时间窗: 16 months
To determine feasibility of a randomized trial with REBOOT, we will calculate screening and visit completion rates from the study database, with exact 95% confidence intervals (CIs), overall and by arm. Between-group differences will be assessed using Fisher's exact and Wilcoxon ranksum tests. We will calculate Kaplan-Meier curves for time to dropout, by group, and test for differences using the log-rank test.
Acceptability of REBOOT
时间窗: 16 months
To determine acceptability of REBOOT, we will calculate counseling completion rates from the study database by visit, and tabulate the proportions of active arm participants attending 0-4 counseling sessions. Via ACASI, we will inquire about participant satisfaction with the intervention and belief that it affected their drug use behaviors; responses will be presented as means, medians, or proportions, as appropriate, with 95% CIs.
Influence of egocentric social network characteristics on overdose events and naloxone use
时间窗: 16 months
To evaluate the influence of egocentric social network characteristics on overdose events and naloxone use, we will use GEE Poisson models with robust standard errors to evaluate the association between network size, evaluated at baseline and each return visit, and numbers of experienced and witnessed overdose events in the same period; zero-inflated models will be used if needed. In addition, we will explore the influence of homophily and assortativity on experienced and witnessed overdose events using similar methods. Newman's method will be used to calculate assortativity coefficients, a measure of the degree of demographic and risk behavior similarity within participants' egocentric networks.
次要结局
未报告次要终点
研究者
Phillip Coffin, MD, MIA
Director, Substance Use Research Unit
San Francisco Department of Public Health