Improved Strategies for Outpatient Opioid Detoxification

门诊阿片类药物戒毒的改进策略

基本信息

批准号：
8027870
负责人：
Maria A Sullivan
金额：
$ 64.02万
依托单位：
NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-06-01 至 2016-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8027870
关键词：
Abstinence Adjuvant Analgesic Aftercare Agonist Alcohol or Other Drugs use Buprenorphine Clinical Clinical Trials Clonazepam Clonidine Commit Data Dependence Diagnosis Dose Drug Formulations Drug Metabolic Detoxication Ensure Face Funding Goals Guidelines Hospitalization Individual Injectable Injection of therapeutic agent Inpatients Insurance Investigation Maintenance Methadone Methods Modification Moods Naloxone Naltrexone Narcotic Antagonists Occupational Opiate Addiction Opiates Opioid Oral Outcome Outpatients Participant Patients Pattern Pharmacotherapy Procedures Randomized Recruitment Activity Recurrence Regimen Relapse Replacement Therapy Research Research Personnel Safety Schedule Supportive care Techniques Time Treatment Protocols Visit Withdrawal arm base clinical practice disorder later incidence prevention experience follow-up improved meetings mortality mu opioid receptors novel novel strategies prescription opioid primary outcome secondary outcome success treatment adherence trial comparing two-arm study

项目摘要

DESCRIPTION (provided by applicant): Clinicians and clinical researchers engaged in opioid dependence treatment face a clear clinical imperative to improve detoxification strategies in order to avoid the pattern of early relapse and recurrent need for detoxification that characterizes present treatment efforts in this field. While agonist maintenance with methadone or buprenorphine represents the most effective strategy for ensuring long-term treatment retention, opioid replacement therapy is unacceptable to many opioid addicts, particularly those recently diagnosed or the growing proportion of prescription opioid abusers often unwilling to commit to years of opioid maintenance. Efforts to employ a gradual dose reduction of buprenorphine, in a seven- or twenty-eight-day taper, have met with very limited success to date. The addition of naltrexone, a mu opioid receptor antagonist, following buprenorphine taper represents a novel strategy for improving success of the opioid detoxification. In current clinical practice, the requirement for an inpatient detoxification in order to undergo naltrexone induction has constituted a significant barrier to opioid antagonist therapy, because of both patient unacceptability and rising insurance limitations on inpatient treatment. The investigators' extensive experience using antagonist-based treatment of opioid dependence supports the feasibility of implementing an outpatient naltrexone induction procedure. The recently available long-acting injectable formulation of naltrexone, for which FDA approval for opioid dependence is currently being sought, makes this application especially timely. Clear guidelines are needed for the effective induction onto naltrexone following the buprenorphine taper method of opioid detoxification. The proposed investigation will seek to 1) improve long-term outcomes for the buprenorphine taper method of detoxification by adding naltrexone and 2) develop a procedure using buprenorphine and low-dose naltrexone treatment initiation to permit outpatient induction onto long-acting naltrexone. The naltrexone induction regimen proposed in this project is based on previous extensive research conducted in more than 300 patients over the past 12 years by this group of investigators, demonstrating the safety and tolerability of the oral induction strategy in an inpatient setting. In addition, pilot data from the current funding cycle demonstrates the investigators' ability successfully to carry out outpatient naltrexone inductions, leading to long-term retention in treatment and sustained abstinence. Participants seeking opioid detoxification will be randomized to 1) gradual seven-day buprenorphine induction and taper or 2) seven-day buprenorphine with oral naltrexone induction followed by single Vivitrol injection. The primary outcome will be abstinence at Week 5. Secondary outcomes will include successful completion of the seven-day detoxification procedure, abstinence and engagement in treatment through Week 24, mood assessments, and other substance use outcomes. PUBLIC HEALTH RELEVANCE: Current treatment approach for opioid dependence involves a buprenorphine taper method of detoxification; however, relapse rates are as high as 85 percent in the first month after treatment. Opioid agonist maintenance is not an acceptable treatment option for many opioid addicts early in their course of dependence, as well as for newer groups of prescription opioid users. This application seeks to develop and evaluate a novel outpatient opioid detoxification procedure consisting of a buprenorphine/naloxone/Vivitrol induction technique to achieve treatment engagement leading to sustained abstinence.

描述（由申请人提供）：从事阿片类药物依赖治疗的临床医生和临床研究人员面临着改善戒毒策略的明确临床迫切需要，以避免早期复发和反复需要戒毒的模式，这是该领域目前治疗工作的特点。虽然美沙酮或丁丙诺啡激动剂维持是确保长期保留治疗的最有效策略，但阿片类药物替代疗法对于许多阿片类药物成瘾者来说是不可接受的，特别是那些最近被诊断出或越来越多的处方阿片类药物滥用者往往不愿意长期使用阿片类药物维护。迄今为止，以七或二十八天的剂量逐渐减少丁丙诺啡剂量的努力取得的成功非常有限。在丁丙诺啡逐渐减量后添加纳曲酮（一种 mu 阿片受体拮抗剂）代表了一种提高阿片类药物解毒成功率的新策略。在当前的临床实践中，由于患者的不可接受性和住院治疗的保险限制不断增加，为了接受纳曲酮诱导而需要住院戒毒的要求已对阿片类拮抗剂治疗构成了重大障碍。研究人员使用基于拮抗剂的阿片类药物依赖治疗的丰富经验支持了实施门诊纳曲酮诱导程序的可行性。最近推出的纳曲酮长效注射制剂目前正在寻求 FDA 批准用于治疗阿片类药物依赖，这使得这一申请显得尤为及时。在阿片类药物解毒的丁丙诺啡逐渐减量方法之后，需要明确的指南来有效诱导纳曲酮。拟议的研究将寻求 1) 通过添加纳曲酮来改善丁丙诺啡逐渐减量解毒方法的长期结果，2) 开发一种使用丁丙诺啡和低剂量纳曲酮治疗启动的程序，以允许门诊患者诱导使用长效纳曲酮。本项目提出的纳曲酮诱导方案基于该组研究人员过去 12 年对 300 多名患者进行的广泛研究，证明了住院环境中口服诱导策略的安全性和耐受性。此外，当前资助周期的试点数据表明，研究人员有能力成功地进行门诊纳曲酮诱导，从而导致长期保留治疗和持续戒断。寻求阿片类药物戒毒的参与者将被随机分配到 1) 逐渐进行为期 7 天的丁丙诺啡诱导并逐渐减量，或 2) 为期 7 天的丁丙诺啡联合口服纳曲酮诱导，然后进行单次 Vivitrol 注射。主要结果将是第 5 周的戒毒。次要结果将包括成功完成 7 天的戒毒程序、第 24 周的戒毒和参与治疗、情绪评估和其他物质使用结果。公共卫生相关性：目前阿片类药物依赖的治疗方法涉及丁丙诺啡逐渐减量解毒方法；然而，治疗后第一个月的复发率高达 85%。对于许多阿片类药物成瘾者以及新的处方阿片类药物使用者来说，阿片类药物激动剂维持治疗并不是一种可以接受的治疗选择。该申请旨在开发和评估一种新型门诊阿片类药物解毒程序，该程序由丁丙诺啡/纳洛酮/Vivitrol 诱导技术组成，以实现治疗参与，从而实现持续戒断。