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明确的临床要求，以改善排毒策略，以避免早期复发和反复进行排毒的模式，以表征该领域目前治疗工作的特征。虽然用美沙酮或丁丙诺啡维持激动剂是确保长期治疗保留率的最有效策略，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，尤其是那些最近被诊断出的阿片类药物或越来越多的处方阿片类虐待者的比例，通常不愿意承诺多年的阿片类药物维持。迄今为止，在七或二十八天的锥度中采用逐渐减少丁丙诺啡的努力，迄今为止取得了非常有限的成功。丁丙诺啡锥后Naltrexone（MU阿片受体拮抗剂）的添加代表了改善阿片类药物排毒成功的新型策略。在当前的临床实践中，由于患者的无法接受性和住院治疗的保险限制，因此要接受纳曲酮诱导的住院排毒的要求构成了阿片类拮抗剂治疗的重大障碍。研究人员使用基于拮抗剂的阿片类药物依赖性治疗的丰富经验支持实施门诊纳曲酮诱导程序的可行性。最近正在寻求FDA批准阿片类药物依赖的纳曲酮的最近可用的长效注射式配方，使该应用程序尤其及时。在丁丙诺啡锥度的阿片类药物排毒方法之后，需要有效诱导纳曲酮的有效诱导指南。拟议的研究将寻求1）通过添加纳曲酮来改善丁丙诺啡锥的排毒方法的长期结局，以及2）使用丁丙诺啡和低剂量纳曲酮治疗起始制定一种程序，以允许在长期行动的纳曲丁酮上进行门诊诱导。该项目中提出的Naltrexone诱导方案是基于这组研究人员在过去12年中对300多名患者进行的以前的广泛研究，证明了在住院环境中口服诱导策略的安全性和耐受性。此外，当前资金周期的试点数据证明了研究人员成功执行门诊纳曲酮诱导的能力，从而导致长期保留在治疗和持续的戒烟方面。寻求阿片类药物排毒的参与者将被随机分为1）逐渐七天的丁丙诺啡诱导和锥度逐渐变细或2）七天的丁丙诺啡带有口服纳曲酮诱导，然后进行单生体内注射。主要结果将是在第5周的节制。次要结果将包括成功完成为期7天的排毒程序，节制和通过第24周的治疗，情绪评估以及其他物质使用结果。公共卫生相关性：阿片类药物依赖性的当前治疗方法涉及丁丙诺啡锥的排毒方法；但是，治疗后的第一个月，复发率高达85％。对于许多阿片类药物的依赖以及新的处方阿片类药物用户的群体，阿片类药物的维护不是许多阿片类药物上瘾者的可接受治疗选择。该应用程序旨在开发和评估一种新型门诊阿片类药物排毒程序，该程序由丁丙诺啡/纳洛酮/纳洛酮/乙醇诱导技术组成，以实现治疗参与，从而导致持续的戒酒。