Opioid Maintenance: Optimal Stabilization & Withdrawal

描述：（申请人提供） 阿片类药物依赖是一个反复出现的问题。美沙酮和LAAM有效 在许多方面类似的治疗剂。然而，剂量的一些特征是 没有很好的定义。将进行两项研究，检查给药和剂量 减少阿片类药物依赖的激动剂（LAAM）治疗策略。结果 两个相互联系，但不同的，LAAM管理的研究将是 可推广到美沙酮或丁丙诺啡。 研究I将是一项为期5个月的盲态给药研究，具有3个剂量稳定期 策略和认知行为疗法（CBT）基线。将有三 每组26名受试者：1）基于mg/kg体重/天的LAAM稳定+CBT (e.g.,在70公斤，剂量将是每周490，分布在29%星期一， 周三29%，周五42%; 2）LAAM稳定基于 阿片类药物阴性尿液筛查和自我报告症状+CBT; 3）LAAM 每天50 mg当量+CBT的稳定（即，每周分发350份 29%，29%，42%）。所有受试者将接受 SCID、药物史和基于我们定义明确且 严格的技术。尿液检查呈阳性且有明确的使用证据， 将需要沿着5年使用的证据。可卡因和其他药物 将测量摄入时和治疗期间的使用情况，但不作为一种条件 进入或排除。然而，同时依赖（尼古丁除外）将 要排外。本研究将阐明给药策略。这项研究是 基于我们对美沙酮的研究，使用1.1 mg/kg美沙酮剂量的经验， 与临床医生和研究人员讨论，美沙酮和LAAM 文学 研究II将在六个月的时间内检查剂量减少策略。 基线治疗将加强临床管理， 在研究I中获得的技能。仅入组研究I并符合 入选标准（低阳性率阿片类药物筛查和测量的"准备 “改变”将被接受。剂量分配与研究I相同（29 %/29%/42%）。LAAM剂量减少约10 %至初始剂量的15 - 20%，然后停药。两 每组28例受试者，将1）盲态剂量减少和2）开放剂量 还原筛选/测量将与研究I一样继续进行。盲组 受试者将继续接受安慰剂直至研究结束。甚至保留受试者 达到停药后将允许直接随访，并将有一个 末次访视后1个月随访。这项工作扩展了我们最初的 盲开手术的初步检查。 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.