Improved Strategies for Outpatient Opioid Detoxification

门诊阿片类药物戒毒的改进策略

• 批准号: 8841700
• 负责人: ADAM BISAGA
• 金额: $ 65.27万
• 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 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8841700
• 关键词: Abstinence; Adjuvant Analgesic; Aftercare; Agonist; Alcohol or Other Drugs use; Buprenorphine; Clinical; Clinical Trials; Clonazepam; Clonidine; 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着改善戒毒策略的明确临床必要性，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的激动剂维持是确保长期维持治疗的最有效策略，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承诺维持多年的阿片类药物。丁丙诺啡在7天或28天内逐渐减少剂量的努力迄今为止取得了非常有限的成功。在丁丙诺啡逐渐减少后加入纳曲酮，一种阿片受体拮抗剂，代表了一种提高阿片解毒成功率的新策略。在目前的临床实践中，由于患者的不可接受性和住院治疗的保险限制不断增加，住院患者需要戒毒才能接受纳曲酮诱导，这对阿片类拮抗剂治疗构成了重大障碍。研究者使用拮抗剂治疗阿片类药物依赖的丰富经验支持实施门诊纳曲酮诱导程序的可行性。最近可用的长效注射制剂纳曲酮，目前正在寻求FDA批准阿片类药物依赖，使得该申请特别及时。需要明确的指导方针，在丁丙诺啡逐渐减少阿片类药物解毒的方法后，有效地诱导纳曲酮。拟议的研究将寻求1)通过添加纳曲酮改善丁丙诺啡逐渐戒毒方法的长期结果，2)开发一种使用丁丙诺啡和低剂量纳曲酮治疗起始的程序，以允许门诊诱导使用长效纳曲酮。本项目提出的纳曲酮诱导方案是基于该研究小组在过去12年中对300多名患者进行的广泛研究，证明了口服诱导策略在住院患者中的安全性和耐受性。此外，来自当前资助周期的试点数据表明，研究人员有能力成功地开展门诊纳曲酮诱导，导致长期保留治疗和持续戒断。寻求阿片类药物解毒的参与者将随机分为1)逐渐7天丁丙诺啡诱导和逐渐减少或2)7天丁丙诺啡联合口服纳曲酮诱导，然后单次注射维诺醇。主要结果将是第5周的戒断。次要结果将包括成功完成为期7天的戒毒程序，在第24周内戒断和参与治疗，情绪评估和其他物质使用结果。