Developing a Prescription Opioid Overdose Prevention Intervention

制定处方阿片类药物过量预防干预措施

• 批准号: 8811923
• 负责人: Amy S B Bohnert
• 金额: $ 29.65万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-01 至 2017-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8811923
• 关键词: AIDS prevention; Acute; Address; Adult; Aftercare; Alcohol consumption; Analgesics; Antidotes; Attention; Behavior Therapy; Benzodiazepines; Categories; Cause of Death; Cessation of life; Communities; Coupled; Data; Drug Tolerance; Drug Use Disorder; Drug usage; Evidence based practice; Female; Future; Gender; Goals; HIV; HIV Infections; HIV risk; Health; Heroin Users; Individual; Injection of therapeutic agent; Intervention; Knowledge; Mediating; Medical; Naloxone; Observational Study; Opioid; Outcome; Overdose; Participant; Patient risk; Patients; Pharmaceutical Preparations; Poisoning; Prevention program; Prevention strategy; Preventive Intervention; Procedures; Public Health; Randomized; Randomized Controlled Trials; Recruitment Activity; Reporting; Research; Risk; Risk Behaviors; Risk Factors; Risk Reduction; Self Efficacy; Social Network; Staging; Substance Use Disorder; Symptoms; Training; Treatment Efficacy; Variant; Woman; Work; addiction; base; design; efficacy evaluation; efficacy trial; evidence base; follow-up; group intervention; heroin overdose; high risk; improved; innovation; male; men; mortality; novel; overdose death; overdose prevention; pilot trial; prescription opioid; prevent; programs; response; trial comparing

DESCRIPTION (provided by applicant): Unintentional overdose deaths increased 173% among U.S. adults between 1999 and 2010. This change is mostly due to increases in fatal opioid pain medication overdoses, which now greatly exceed deaths due to heroin overdose. For those with substance use disorders (SUDs), overdose is a leading cause of death, and the period after treatment for SUDs is high risk for overdose. Non-medical use of opioids is common among individuals with SUDs. Despite this, there are few interventions to reduce opioid medication overdose risk for those in SUD treatment. This project will develop a three-session intervention to reduce overdose risk behavior among individuals in SUD treatment with recent non-medical opioid use. The content will focus on opioid medication overdoses specifically, and will be based on: (a) motivational enhancement, which has been found to reduce risky alcohol use, and (b) overdose witness interventions, which have been used to train heroin users on overdose response. The intervention will also incorporate content on reducing risk of HIV infection given the opportunity to reach individuals at elevated risk for HIV and the overlap in HIV and overdose risk behaviors (e.g., injecting opioid medications and other drugs). After refining intervention content, a pilot randomized controlled trial will provide the preliminary dat needed to inform the design of a future large-scale evaluation of the efficacy of the intervention. Specifically, 60 men and 60 women will be randomized to the intervention or an attention control condition. Assessments will be conducted at baseline, at the completion of intervention/control procedures, and three and six months later. The specific aims are to: (1) refine a motivational enhancement prevention intervention for prescription opioid overdose risk reduction and improved witnessed overdose response for at-risk patients in addictions treatment; (2) conduct a pilot randomized controlled trial comparing the prescription opioid overdose prevention intervention to a supportive educational control condition for patients in addictions treatment in order to: (a) obtain information about the feasibility of randomized controlled procedures; and (b) determine the distribution and variability of the primary (overdose risk behaviors) and mediating/secondary (witnessed overdose response, self-efficacy to reduce overdose risk, knowledge of overdose risk factors and symptom recognition) outcomes; and (3) determine the distribution and variability in changes in HIV risk behaviors (e.g., reductions in injection of prescription opioids) over follow-up. A secondary aim of the proposal is to examine the variation in outcomes within sub-groups of participants defined by group (intervention vs. control) and gender. This study will provide crucial initial data on an innovative new strategy to prevent prescription opioid overdoses. The project will also provide initial data on the potential for integrating overdose and HIV prevention. The public health significance of this project is amplified by the combining of strategies to reduce participants' overdose risk with strategies to improve survival for individuals who overdose in the presence of participants.

描述（由申请人提供）：1999 年至 2010 年间，美国成年人意外用药过量死亡人数增加了 173%。这一变化主要是由于致命的阿片类止痛药过量服用的增加，目前已大大超过海洛因过量导致的死亡人数。对于患有物质使用障碍 (SUD) 的患者来说，药物过量是导致死亡的主要原因，而 SUD 治疗后的时期是药物过量的高风险期。阿片类药物的非医疗使用在 SUD 患者中很常见。尽管如此，很少有干预措施可以降低接受 SUD 治疗的阿片类药物过量风险。该项目将开发一项三期干预措施，以减少最近使用非医疗阿片类药物的 SUD 治疗个体的过量风险行为。内容将专门关注阿片类药物过量，并将基于：(a) 动机增强，已发现可以减少危险的饮酒，以及 (b) 过量证人干预，已用于培训海洛因使用者过量服用回复。该干预措施还将纳入降低艾滋病毒感染风险的内容，因为有机会接触艾滋病毒高危人群，以及艾滋病毒和过量风险行为（例如注射阿片类药物和其他药物）的重叠。完善干预内容后，试点随机对照试验将提供所需的初步数据，为未来大规模干预效果评估的设计提供信息。 具体来说，60 名男性和 60 名女性将被随机分配接受干预或注意力控制条件。评估将在基线、干预/控制程序完成时以及三个月和六个月后进行。具体目标是：（1）完善动机增强预防干预措施，以降低处方阿片类药物过量风险，并改善成瘾治疗中高风险患者的目击过量反应； (2) 开展一项试点随机对照试验，将处方阿片类药物过量预防干预措施与成瘾治疗患者的支持性教育控制条件进行比较，以便： (a) 获得有关随机对照程序可行性的信息； (b) 确定主要（用药过量风险行为）和中介/次要（目睹的用药过量反应、降低用药过量风险的自我效能、对用药过量风险因素的了解和症状识别）结果的分布和变异性； (3) 确定随访期间艾滋病毒风险行为变化的分布和变异性（例如，处方阿片类药物注射的减少）。该提案的第二个目标是检查按群体（干预与控制）和性别定义的参与者亚组内结果的差异。这项研究将为预防处方阿片类药物过量的创新策略提供重要的初始数据。该项目还将提供有关整合过量用药和艾滋病毒预防的潜力的初步数据。通过将降低参与者服药过量风险的策略与提高在参与者在场的情况下服药过量的个人的生存率的策略相结合，放大了该项目的公共卫生意义。