Impact of PTSD and trauma reexposure on buprenorphine maintenance treatment in syringe exchange programs

注射器交换项目中 PTSD 和创伤再暴露对丁丙诺啡维持治疗的影响

• 批准号: 10115954
• 负责人: Aaron D Fox
• 金额: $ 10.37万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10115954
• 关键词: Abstinence; Affect; Buprenorphine; Caring; Client; Clinical; Clinical Investigator; Data; Development; Development Plans; Diagnosis; Drug Screening; Enrollment; Focus Groups; Foxes; Grant; HIV; HIV risk; Health Services; Injecting drug user; Injections; Intervention; Interview; Knowledge; Maintenance; Medical; Methods; Needle-Exchange Programs; Neighborhood Health Center; Opioid; Participant; Patient Self-Report; Pharmaceutical Preparations; Population; Post-Traumatic Stress Disorders; Prevention; Provider; Psychologist; Randomized; Randomized Controlled Trials; Research; Research Personnel; Risk; Risk Behaviors; Severities; Sterility; Structure; Symptoms; Syringes; Testing; Time; Trauma; Treatment Efficacy; United States; Urine; Visit; base; buprenorphine treatment; career development; community clinic; design; drug use behavior; experience; illicit opioid; novel; opioid use; opioid use disorder; opioid user; overdose death; prospective; recruit; stress related disorder; symptomatology; traumatic event; treatment risk; treatment strategy; urban area

In the United States, opioid use disorder (OUD) and overdose deaths are increasing; yet 80% of people with OUD remain out of treatment. Operating in 33 states, syringe exchange programs (SEPs), which provide sterile syringes and other health services to people who inject drugs, are a key venue to reach out-of-treatment opioid users. In a 24-week randomized controlled trial based in a large urban area with high rates of OUD and HIV, Project BLOOM (R01DA044878, [PI: Fox]) will recruit 250 out-of-treatment opioid users who utilize SEPs and randomize 1:1 to onsite buprenorphine treatment (O-BMT) or enhanced referral. Over two weeks, participants in the O-BMT condition will see a buprenorphine provider twice onsite, receive weekly medication packs, and then their care will be transferred to a community health center for maintenance buprenorphine treatment. The proposed diversity supplement will support Dr. Teresa López-Castro, a clinical psychologist and early-stage investigator, to study barriers to engagement in buprenorphine treatment that are related to Post- Traumatic Stress Disorder (PTSD) and traumatic event re-exposure. Project BLOOM has identified structural barriers to OUD treatment and is testing SEP-based buprenorphine initiation as a way to minimize delays in starting buprenorphine treatment. However, PTSD and the experiencing of new traumatic events (traumatic event re-exposure) are exceedingly common among people with OUD, affect drug use behaviors, and will likely modify O-BMT’s effects. Thus designing novel engagement and treatment strategies requires consideration of PTSD and traumatic event re-exposure. The objectives of the proposed mixed methods study are two-fold: (1) to quantitatively evaluate the moderating effect of PTSD and traumatic event re-exposure on the efficacy of O-BMT; and (2) to collect qualitative data from stakeholders (SEP consumers and staff) on the PTSD-related treatment needs for IDUs. The proposed two-year diversity supplement will create generalizable knowledge regarding how PTSD and traumatic event re- exposure impact buprenorphine treatment efficacy. The application also proposes a comprehensive career development plan that will also support Dr. López-Castro’s further development as a clinical investigator.

在美国，阿片类药物使用障碍（OUD）和过量死亡人数仍在增加； 80% 的 OUD 患者仍未接受治疗，在 33 个州进行注射器更换。 计划 (SEP)，为注射者提供无菌注射器和其他卫生服务 在为期 24 周的随机试验中，药物是接触停止治疗的阿片类药物使用者的关键途径。 BLOOM 项目在 OUD 和 HIV 发病率较高的大城市地区开展对照试验 （R01DA044878，[PI：Fox]）将招募 250 名停止治疗的阿片类药物使用者，他们使用 SEP 和 以 1:1 的比例随机分配至现场丁丙诺啡治疗 (O-BMT) 或超过 2 人的强化转诊。 几周后，O-BMT 条件下的参与者将在现场两次见到丁丙诺啡提供者， 每周收到药物包，然后他们的护理将转移到社区卫生机构 维持丁丙诺啡治疗中心拟议的多样性补充将。 支持临床心理学家和早期研究员 Teresa López-Castro 博士 研究与术后相关的参与丁丙诺啡治疗的障碍 BLOOM 项目涉及创伤性应激障碍 (PTSD) 和创伤性事件的再暴露。 确定了 OUD 治疗的结构性障碍，并正在测试基于 SEP 的丁丙诺啡起始治疗 作为一种尽量减少开始丁丙诺啡治疗的延迟的方法，但是，PTSD 和 经历新的创伤事件（创伤事件再次暴露）非常常见 在 OUD 患者中，影响药物使用行为，并可能改变 O-BMT 的效果。 因此，设计新的参与和治疗策略需要考虑创伤后应激障碍（PTSD）和 所提出的混合方法研究的目标有两个： (1)定量评估PTSD和创伤事件再暴露对创伤事件的调节作用 O-BMT 的功效；(2) 从利益相关者（SEP 消费者）收集定性数据 和工作人员）关于注射吸毒者与创伤后应激障碍（PTSD）相关的治疗需求的建议的两年多样性。 补充品将创造关于创伤后应激障碍（PTSD）和创伤事件如何重新治疗的普遍知识。 该申请还提出了暴露影响丁丙诺啡治疗功效的方法。 全面的职业发展计划也将支持洛佩斯-卡斯特罗博士的进一步发展 作为一名临床研究者的发展。