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: 8636645
• 负责人: Amy S B Bohnert
• 金额: $ 26.4万
• 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/8636645
• 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; Heroin Users; Individual; Injection of therapeutic agent; Intervention; Knowledge; Mediating; Medical; Naloxone; Observational Study; Opioid; Outcome; Overdose; Participant; 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; public health relevance; 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）：在1999年至2010年之间，美国成年人的意外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的增加，现在由于海洛因过量导致的死亡而大大超过了死亡。对于患有药物使用障碍（SUD）的人，用药过量是死亡的主要原因，而接受SUD的治疗期是过量的高风险。阿片类药物的非医学使用在有SUD的个体中很常见。尽管如此，很少有干预措施可以减少阿片类药物治疗患者的过量风险。该项目将开发三项干预措施，以减少SUD治疗中最近非医疗阿片类药物的过量风险行为。该内容将专门针对阿片类药物过量服用，并基于以下基础：（a）激励性增强（已被发现可以减少危险的饮酒，以及（b）过量的证人干预措施，这些干预措施已被用来培训过量用药的海洛因使用者回复。鉴于有机会接触艾滋病毒风险较高的人以及艾滋病毒和过量的风险行为的重叠（例如，注射阿片类药物和其他药物），该干预措施还将纳入降低艾滋病毒感染风险的内容。在精炼干预措施之后，一项试验随机对照试验将提供必要的初步DAT，以告知未来对干预功效的大规模评估。 具体而言，将有60名男性和60名妇女随机分配到干预或注意力控制条件下。评估将在基线，干预/控制程序完成时以及三个月后进行评估。具体的目的是：（1）在成瘾治疗中，针对处方阿片过量风险的处方过量风险降低处方的动机预防干预措施，并改善了对处于危险患者的过量反应； （2）进行一项试验随机对照试验，将处方阿片类药物预防干预与成瘾治疗中患者的支持性教育控制条件进行比较，以：（a）获取有关随机控制程序的可行性的信息； （b） 确定原发性（过量风险行为）和介导/次要（见证过量反应，自我效能减少过量风险，对过量风险因素的知识和症状识别的知识）的分布和变异性； （3）确定艾滋病毒风险行为变化的分布和变化（例如，处方阿片类药物注入的减少）对随访的情况。该提案的次要目的是检查小组定义的参与者（干预与控制）和性别的参与者子组中结果的变化。这项研究将提供有关一种创新的新策略的关键初始数据，以防止处方阿片类药物过量。该项目还将提供有关整合过量和艾滋病毒预防的潜力的初始数据。通过将参与者过量风险与改善参与者在场的个人改善生存的策略相结合来扩大该项目的公共健康意义。