Improved Strategies for Outpatient Opioid Detoxification

门诊阿片类药物戒毒的改进策略

• 批准号: 8656670
• 负责人: ADAM BISAGA
• 金额: $ 61.5万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 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/8656670
• 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; public health relevance; secondary outcome; success; treatment adherence; trial comparing; two-arm study

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.

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一个明确的临床迫切性，即改善解毒策略，以避免早期复发和反复需要解毒的模式，这是该领域目前治疗工作的特点。虽然美沙酮或丁丙诺啡的激动剂维持是确保长期治疗保留的最有效策略，但阿片类药物替代疗法对许多阿片类药物成瘾者来说是不可接受的，特别是最近诊断的阿片类药物成瘾者或越来越多的处方阿片类药物滥用者往往不愿意承诺多年的阿片类药物维持。采用丁丙诺啡逐渐减量（7天或28天逐渐减量）的努力迄今为止取得的成功非常有限。在丁丙诺啡减量后加入纳洛酮（一种μ阿片受体拮抗剂）代表了一种提高阿片类药物脱毒成功率的新策略。在目前的临床实践中，需要住院戒毒才能接受纳洛酮诱导，这对阿片类药物拮抗剂治疗构成了重大障碍，因为患者不接受和住院治疗的保险限制不断增加。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实施门诊纳洛酮诱导程序的可行性。最近可获得的纳洛酮长效注射制剂，目前正在寻求FDA批准用于阿片类药物依赖，使得这种应用特别及时。需要明确的指导方针，以有效地诱导纳洛酮后，丁丙诺啡锥度阿片类药物脱毒的方法。拟议的研究将寻求1）通过添加纳洛酮改善丁丙诺啡减量脱毒方法的长期结局，2）开发一种使用丁丙诺啡和低剂量纳洛酮治疗启动的程序，以允许门诊患者诱导使用长效纳洛酮。本项目中提出的纳洛酮诱导方案是基于这组研究人员在过去12年中对300多名患者进行的广泛研究，证明了住院患者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洛酮诱导，从而长期保持治疗和持续禁欲。寻求阿片类药物解毒的参与者将被随机分配至1）逐渐7天丁丙诺啡诱导和减量或2）7天丁丙诺啡与口服纳洛酮诱导，然后单次注射Vivitrol。主要结局为第5周时的禁欲。次要结果将包括成功完成为期7天的解毒程序，到第24周的禁欲和参与治疗，情绪评估和其他物质使用结果。