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）：1999年至2010年期间，美国成年人意外过量死亡增加了173%。这一变化主要是由于致命的阿片类止痛药过量的增加，现在大大超过了海洛因过量造成的死亡。对于那些有物质使用障碍（SUD）的人来说，过量是死亡的主要原因，SUD治疗后的时期是过量的高风险。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SUD治疗中阿片类药物过量的风险。该项目将开发一种三次干预措施，以减少最近使用非医疗阿片类药物的SUD治疗中个体的过量风险行为。内容将特别侧重于阿片类药物过量，并将基于：（a）动机增强，已发现这可以减少危险的酒精使用，（B）过量证人干预，已用于对海洛因使用者进行过量反应培训。干预措施还将纳入关于降低艾滋病毒感染风险的内容，因为有机会接触艾滋病毒风险较高的个人，以及艾滋病毒和过量风险行为的重叠（例如，注射阿片类药物和其他药物）。在细化干预内容后，一项试点随机对照试验将提供所需的初步数据，为未来大规模评估干预效果的设计提供信息。 具体而言，60名男性和60名女性将被随机分配到干预或注意力控制条件。将在基线、干预/控制程序完成时以及3个月和6个月后进行评估。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，并改善成瘾治疗中风险患者的目击过量反应;（2）进行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）获得关于随机对照程序的可行性的信息;以及（B） 确定主要（过量风险行为）和介导/次要（目睹过量反应、降低过量风险的自我效能、过量风险因素的知识和症状识别）结果的分布和可变性;以及（3）确定HIV风险行为变化的分布和可变性（例如，减少处方阿片类药物的注射）。该提案的第二个目的是检查按组（干预组与对照组）和性别定义的参与者分组内结果的差异。这项研究将为预防处方阿片类药物过量的创新新策略提供关键的初始数据。该项目还将提供关于将过量用药和艾滋病毒预防结合起来的可能性的初步数据。该项目的公共卫生意义通过将减少参与者过量风险的战略与改善参与者在场时过量的个人生存的战略相结合而得到放大。