Opioid Maintenance: Optimal Stabilization & Withdrawal

描述：(申请人提供) 阿片依赖是一个反复出现的问题。美沙酮和LAAM有效 在许多方面相似的治疗剂。然而，剂量的一些特征是 定义不明确。将进行两项研究，检查剂量和剂量 激动剂(LAAM)治疗阿片依赖的减少策略。结果 在两项相互关联但截然不同的LAAM管理研究中， 可推广到美沙酮或丁丙诺啡。 研究I将进行为期5个月的三剂量稳定的盲法给药研究 策略和认知行为疗法(CBT)基础4。会有三个人 每组26名受试者：1)基于mg/kg体重/天+CBT的LAAM稳定度 (例如，在70公斤时，剂量将为每周490次，周一分配29%， 周三和周五分别为29%和42%；2)LAAM稳定基于 阿片类药物阴性尿筛查和自我报告症状+CBT；3)LAAM 稳定在每天50毫克当量+CBT(即每周分发350毫克) 29%、29%、42%)。所有受试者都将接受筛选 SCID，药物历史和医学评估，基于我们定义良好的 严谨的技术。阳性尿液筛查和当前使用的明确证据， 还需要5年的使用证明。可卡因和其他毒品 摄入量和治疗期间的使用量将被测量，但不会成为一种情况 用于进入或排除。然而，并发依赖(尼古丁除外)将 排他性的。这项研究将阐明给药策略。这项研究是 根据我们对美沙酮的研究，使用1.1毫克/公斤的美沙酮剂量， 与临床医生和研究人员的讨论，以及美沙酮和LAAM 文学。 第二项研究将在六个月内研究减少剂量的策略。 基线治疗将加强临床管理，召回/回顾 在研究I中获得的技能。只有参加研究I并符合 入选标准(低比率阳性阿片类药物筛查和测量的“准备就绪” 将被接受。剂量将如研究I(29)所述进行分配 百分比/29%/42%)。LAAM剂量将减少约10% 每周增加到初始剂量的15%-20%，然后停止使用。二 每组28名受试者将接受1)盲法剂量减少和2)开放剂量 还原。筛查/测量将继续进行，如研究一所示。盲人组 受试者将继续接受安慰剂治疗，直到研究结束。甚至保留科目 在达到停药后将允许直接跟进，并将有 最后一次就诊后随访一个月。这项工作扩展了我们最初的 对盲开程序的初步审查。 结合起来，这两项研究将阐明不同剂量的后果 战略，并应加强治疗。

DESCRIPTION: (provided by applicant) Opioid dependence is a recurring problem. Methadone and LAAM are effective therapeutic agents similar in many respects. Yet some features of dosing are not well defined. Two studies will be conducted examining dosing and dose reduction strategies in agonist (LAAM) treatment of opioid dependence. Results of the two linked, but distinct, studies of LAAM administration will be generalizable to methadone or buprenorphine. Study I will be a 5 month blind dosing study with three dose stabilization strategies and a Cognitive Behavior Therapy (CBT) base4ine. There will be three groups of 26 subjects each: 1) LAAM stabilization based on mg/kg weight/day+CBT (e.g., at 70 kg, dose will be 490 per week, distributed at 29 percent Monday, 29 percent Wednesday, and 42 percent Friday; 2) LAAM stabilization based on opioid negative urine screens and self reported symptoms+CBT; 3) LAAM stabilization at 50 mg per day equivalent+CBT (i.e., 350 per week distributed 29 percent, 29 percent, 42 percent). All subjects will be screened with the SCID, drug history, and medical evaluation based on our well-defined and rigorous techniques. A positive urine screen and clear evidence of current use, along with evidence of 5 years of use will be required. Cocaine and other drug use at intake and during treatment will be measured but will not be a condition for entry or exclusion. However, concurrent dependence (except nicotine) will be exclusionary. This study will elucidate dosing strategies. The study is based an our work with methadone, experience using a 1.1 mg/kg methadone dose, discussion with clinicians and researchers, and the methadone and LAAM literature. Study II will examine dose reduction strategies over a six-month period. Baseline therapy will be enhanced Clinical Management that recalls/reviews skills acquired in Study I. Only subjects enrolled in Study I and meeting the criteria for entry (low rate positive opioid screens and measured "Readiness to Change") will be accepted. Dose will be distributed as in Study I (29 percent/29 percent/42 percent). LAAM dose reduction will be at approximately 10 percent per week to 15-20 percent of initial dose and then discontinued. Two groups, 28 subjects each, will be 1) blind dose reduction and 2) open dose reduction. Screening/measurement will continue as in Study I. Blind group subjects will continue to receive placebo to study end. Retaining subjects even after reaching discontinuation will permit direct follow-up and there will be a one-month follow-up after the last visit. The work extends our initial preliminary examination of the blind-open procedure. In combination, the two studies will elucidate consequences of different dosing strategies and should enhance treatment.