Distress Tolerance and HIV Prevention with XR-NTX Initiation in Opioid Dependence

使用 XR-NTX 启动阿片类药物依赖性的应激耐受性和 HIV 预防

• 批准号: 9000682
• 负责人: Susan E Ramsey
• 金额: $ 27.55万
• 依托单位: RHODE ISLAND HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-02-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9000682
• 关键词: AIDS prevention; Abstinence; Ache; Adaptive Behaviors; Address; Affective; Agitation; Alcohol or Other Drugs use; Anxiety; Behavior; Behavior Therapy; Behavioral; Clinical; Clinical Trials; Cognitive; Combination Medication; Data; Detoxification Process; Development; Drug Metabolic Detoxication; Elements; Fatigue; Feedback; Future; HIV risk; HIV/STD; HIV/STI intervention; Health; Human immunodeficiency virus test; Individual; Injection of therapeutic agent; Intervention; Interview; Knowledge; Life; Manuals; Mediating; Mental Depression; Modification; Naltrexone; Narcotic Antagonists; National Institute of Drug Abuse; Needle Sharing; Opiate Addiction; Opioid; Outcome; Participant; Patients; Pharmaceutical Preparations; Phase; Process; Randomized; Randomized Controlled Trials; Readiness; Relapse; Research; Risk; Risk Behaviors; Risk Reduction; Site; Sleeplessness; Specific qualifier value; Staging; System; Technology; Testing; Time; Training; Tremor; Unsafe Sex; Videoconferences; Videoconferencing; Vomiting; Withdrawal; Withdrawal Symptom; base; distress tolerance; effective therapy; experience; flexibility; illicit drug use; improved; meetings; novel; opioid use; opioid withdrawal; phase 1 study; phase 2 study; physical symptom; programs; psychologic; psychological symptom; psychosocial; sex risk; skills; successful intervention; telehealth; therapy development; treatment as usual

 DESCRIPTION: Opioid dependence is a serious and increasingly pervasive problem. Opioid dependent individuals are at significantly increased risk for a wide range of physical and psychological problems including HIV and STIs. Extended-release naltrexone (XR-NTX) is an effective treatment for opioid dependence, but it requires that opioid-dependent individuals be completely opioid-free prior to its initiation to avoid precipitated withdrawal. The great majorityof individuals attempting to cease opioid use will relapse before initiation of XR-NTX because of opioid withdrawal symptoms during detoxification. Distress Tolerance (DT) focused psychosocial interventions are well suited to address the clinical phenomena experienced by individuals withdrawing from opioids. The present proposal is to develop a DT intervention to improve detoxification outcomes and an active comparison intervention targeting HIV and STI (HIV/STI) risk behavior. The DT intervention will be adapted from Acceptance and Commitment Therapy (ACT). The HIV/STI risk behavior intervention will target behaviors that put patients at risk for HIV and STIs including unprotected sex and needle sharing, as well as promoting regular HIV testing. Both interventions will be delivered through a telehealth videoconferencing system. If the HIV/STI intervention is found to result in reduced HIV/STI risk behavior and more frequent HIV testing, relative to the DT intervention, we will incorporate its components into the DT intervention prior to launching a large- scale clinical trial. The long-term objective of this research program is to improve substance use and HIV/STI outcomes for opioid dependent individuals attempting to cease opioid use. In Phase 1 of the proposed project, we will develop and pilot a DT intervention for individuals transitioning to XR-NTX and a time-matched HIV/STI risk reduction comparison intervention; both will be developed using an iterative process of piloting and modification based on data collected from pilot participants. In Phase 2, opioid dependent individuals transitioning to XR-NTX will be randomly assigned to DT, HIV/STI, or Treatment-As-Usual. All patients will receive medication assisted detoxification from the study recruitment site. We expect that, as a result of this project, we will have developed a well-specified and novel DT intervention tailored to meet the needs of opioid dependent patients transitioning to XR-NTX, the efficacy of which can be further tested in future Stage II randomized controlled trials. If found to be efficacious, this intervention will serve as an effectve means of facilitating detoxification and opioid antagonist initiation, reducing the individual and societal burden due to opioid dependence.

 阿片类药物依赖是一个严重且日益普遍的问题。阿片类药物依赖者面临的各种身体和心理问题，包括艾滋病毒和性传播感染的风险显着增加。缓释纳洛酮（XR-NTX）是阿片类药物依赖的有效治疗方法，但它要求阿片类药物依赖者在开始前完全不含阿片类药物，以避免突然戒断。绝大多数试图停止使用阿片类药物的人在开始XR-NTX之前会复发，因为在戒毒期间出现阿片类药物戒断症状。以痛苦耐受力（DT）为重点的心理社会干预非常适合解决阿片类药物戒断个体所经历的临床现象。目前的建议是制定一个DT干预，以改善戒毒的结果和积极的比较干预，针对艾滋病毒和性传播感染（艾滋病毒/性传播感染）的风险行为。DT干预将改编自接受和承诺疗法（ACT）。艾滋病毒/性传播感染风险行为干预将针对使患者面临艾滋病毒和性传播感染风险的行为，包括无保护性行为和共用针头，以及促进定期艾滋病毒检测。这两项干预措施都将通过远程保健视频会议系统提供。如果发现艾滋病毒/性传播感染干预措施导致艾滋病毒/性传播感染风险行为减少和更频繁的艾滋病毒检测，相对于DT干预措施，我们将在启动大规模临床试验之前将其组成部分纳入DT干预措施。这项研究计划的长期目标是改善试图停止使用阿片类药物的阿片类药物依赖者的物质使用和艾滋病毒/性传播疾病的结果。在拟议项目的第一阶段，我们将为过渡到XR-NTX的个人开发和试点DT干预措施，以及时间匹配的艾滋病毒/性病风险降低比较干预措施;两者都将根据从试点参与者收集的数据，使用试点和修改的迭代过程进行开发。在第2阶段，过渡到XR-NTX的阿片类药物依赖个体将被随机分配到DT，HIV/STI或治疗。所有患者将接受研究招募中心提供的药物辅助戒毒。我们预计，作为该项目的结果，我们将开发出一种针对阿片类药物依赖患者过渡到XR-NTX的需求而量身定制的明确和新颖的DT干预措施，其疗效可以在未来的II期随机对照试验中进一步测试。如果发现是有效的，这种干预将作为一种有效的手段，促进戒毒和阿片类拮抗剂的启动，减少个人和社会负担，由于阿片类药物依赖。

项目成果

The Need for Psychosocial Interventions to Facilitate the Transition to Extended-Release Naltrexone (XR-NTX) Treatment for Opioid Dependence: A Concise Review of the Literature.

• DOI: 10.4137/sart.s39067
• 发表时间: 2016
• 期刊: Substance abuse : research and treatment
• 作者: Ramsey SE;Rounsaville D;Hoskinson R;Park TW;Ames EG;Neirinckx VD;Friedmann P
• 通讯作者: Friedmann P