Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Nalo

描述（由申请人提供）：药物中毒现在是美国成人意外死亡的主要原因。阿片类药物过量是最大的原因，占海洛因使用者死亡率的一半，解决阿片类药物过量与白宫将药物引起的发病率和死亡率降低15%的目标一致。在旧金山弗朗西斯科，初级保健中26%的阿片类药物过量死者是艾滋病毒阳性。旧金山弗朗西斯科是阿片类药物使用和相关发病率的主要城市，2004年通过药物过量预防和教育项目在全市范围内分发纳洛酮（用于逆转阿片类药物过量的短效阿片类拮抗剂）。纳洛酮分布与减少过量死亡以及减少药物相关的HIV风险行为有关，而过量与随后的药物滥用治疗登记有关。过量教育与纳洛酮配对已证明在培训吸毒者方面有效;然而，研究表明需要重复教育课程以保持有效性，动机咨询的附加效应尚不清楚。我们提出了一项重复剂量简短干预的随机对照试验，以减少纳洛酮接受者（REBOOT）的过量和风险行为，结合既定的过量教育课程和动机访谈原则，以解决个人和目击阿片类药物过量。本研究将评价REBOOT与常规治疗相比的可行性和可接受性，评估社交网络特征与过量结局之间的关系，并在60名既往阿片类药物过量的阿片类药物依赖性纳洛酮接受者中探索REBOOT对过量事件（非致死性或死亡）时间、药物使用停止以及过量和HIV风险行为的疗效。干预组的参与者将接受45分钟的咨询会议，讨论个人和目击的过量用药，改变药物使用和艾滋病毒风险行为的动机，以及在第0个月，第4个月，第8个月和第12个月管理过量用药的技能，由训练有素的咨询师提供。将在第0、4、8、12和16个月通过音频计算机辅助自我访谈收集关于过量事件、社交网络特征、物质使用和HIV风险行为的数据;将从病历中获得物质滥用治疗数据。我们将使用精确置信区间估计筛选至入组和访视完成率，并使用对数秩检验比较至脱落的时间（目标1），然后使用Fisher精确和Wilcoxon秩和检验评估可接受性的组间差异（目标2）。具有稳健标准误差的GEE Poisson模型将用于评估社交网络指标与用药过量事件数量和纳洛酮使用之间的关系（目标3）。还将使用泊松模型评价干预对用药过量事件数量的影响（探索性目的）。

DESCRIPTION (provided by applicant): Drug poisoning is now the leading cause of accidental death among adults in the U.S. Opioid overdose, the largest contributor, accounts for half of mortality among heroin users, and addressing opioid overdose is consistent with the White House goal of reducing drug-induced morbidity and mortality by 15%. In San Francisco, 26% of opioid overdose decedents in primary care are HIV-positive. San Francisco, a leading city for opioid use and related morbidity, implemented city-wide distribution of naloxone (the short-acting opioid antagonist used to reverse opioid overdose) in 2004 through the Drug Overdose Prevention & Education Project. Naloxone distribution is associated with reduced overdose death, as well as fewer drug-related HIV risk behaviors, while overdose is associated with subsequent enrollment in substance abuse treatment. Overdose education paired with naloxone has demonstrated efficacy in training drug users; however, research has suggested a need for repeated educational sessions to maintain effectiveness and the additive effect of motivational counseling is unknown. We propose a randomized-controlled trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients (REBOOT), combining an established overdose education curriculum and motivational interviewing principles to address personal and witnessed opioid overdose. This study will evaluate the feasibility and acceptability of REBOOT compared to treatment as usual, assess the relationship between social network characteristics and overdose outcomes, and explore the efficacy of REBOOT on time to overdose events (non-fatal or death), drug use cessation, and overdose and HIV risk behaviors, among 60 opioid-dependent recipients of take-home naloxone who have had a prior opioid overdose. Participants in the intervention arm would receive 45-minute counseling sessions addressing personal and witnessed overdose, motivations to change drug use and HIV risk behaviors, and skills for managing overdose at months 0, 4, 8, and 12, delivered by trained counselors. Data on overdose events, social network characteristics, substance use, and HIV risk behaviors will be collected via Audio Computer Assisted Self Interview at months 0, 4, 8, 12, and 16; substance abuse treatment data will be obtained from medical records. We will estimate screening-to-enrollment and visit completion rates with exact confidence intervals, and compare time to drop-out using the log-rank test (Aim 1), then use Fisher exact and Wilcoxon ranksum tests to assess group differences in acceptability (Aim 2). GEE Poisson models with robust standard errors will be used to assess relationship between social network measures and number of overdose events and naloxone use (Aim 3). Poisson models will also be used to evaluate the effect of the intervention on the numbers of overdose events (exploratory aims).