LAAM WITH BEHAVIORAL TREATMENT FOR OPIOID/COCAINE ABUSE

LAAM 接受阿片类药物/可卡因滥用行为治疗

• 批准号: 6104090
• 负责人: Alison Oliveto
• 金额: $ 11.61万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 1999-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6104090
• 关键词: behavior modification; clinical depression; cocaine; dosage; drug abuse chemotherapy; drug abuse therapy; drug adverse effect; drug screening /evaluation; drug withdrawal; endogenous opioid; functional ability; gender difference; health care cost /financing; human subject; human therapy evaluation; methadylacetate; outcomes research; prognosis; sign /symptom; therapy compliance; urinalysis

Although levo-alpha-acetylmethadol (LAAM), a derivative of methadone, has been successfully used as an alternative to methadone maintenance in opioid addicts, its effect on concurrent opioid and cocaine abuse has not been ascertained. Thus, this study proposed to examine the clinical efficacy of low- and high-dose LAAM maintenance on opioid and cocaine use in opioid-dependent cocaine abusers. In addition, since contingency management procedures have demonstrated some success in decreasing cocaine use in cocaine-abusing individuals, this study also proposes to examine the clinical efficacy of the presence or absence of contingency management procedures targeting illicit drug use. One hundred sixty male and female opioid-dependent cocaine abusers will be stratified by sex and randomly assigned to one of four treatment groups according to a 2 x 2 experiment design: low-dose LAAM (99 mg/wk) with adjunct contingency management procedures; low-dose LAAM (99 mg/wk) without adjunct contingency management procedures; high-dose LAAM (330 mg/wk) with adjunct contingency management procedures; and high-dose LAAM (330 mg/wk) without adjunct contingency management procedures. The duration of the study will be 24 weeks, with LAAM being administered on a thrice-weekly (MWF) basis. Subjects are inducted onto LAAM during weeks 1-3 and then maintained on their assigned maintenance dose (99 mg/wk or 330 mg/wk) through week 24. During maintenance, the Friday dose will be 1.3 times greater that the Monday and Wednesday dose. At the conclusion of the study, subjects undergo detoxification from LAAM over a 4 week period. For those in the contingency management procedure groups, each drug-free urine submitted will result in a voucher worth a certain monetary value that increases for consecutively drug-free urines (weeks 1-12) or a CT State lottery ticket worth $1.00 (weeks 13-24). Vouchers can be exchanged for mutually agreed upon goods and services at any time during the study. Subjects not assigned to the contingency management procedure will receive monetary vouchers (weeks 1-12) or lottery tickets (weeks 13- 24) according to a yoked-control schedule (that is, not contingent upon illicit drug abstinence). Outcome measures will include: 1) treatment retention, 2) illicit drug use, 3) self-reported adverse and opioid withdrawal symptoms, and 4) psychosocial functioning. Prognostic factors (i.e., sex, post-traumatic stress disorder, and depression), will also be examined in relation to treatment outcome. These findings will assist in developing more effective strategies in treating individuals with combined cocaine and opioid dependence.

尽管美沙酮的衍生物左旋α-乙酰美沙醇(LAAM)具有 已成功用作美沙酮维持治疗的替代品 阿片类药物成瘾者，其对阿片类药物和可卡因同时滥用的影响 已被查清。因此，本研究建议检查临床 小剂量和大剂量LAAM维持对阿片类药物和可卡因的疗效 阿片类药物依赖的可卡因滥用者。此外，由于偶发事件 管理程序已显示出一些成功的减少 在可卡因滥用者中使用可卡因，这项研究还建议 检查有无偶然性的临床疗效 针对非法药物使用的管理程序。160名男性 女性阿片依赖可卡因吸毒者将按性别和 根据2x2随机分配到四个治疗组中的一个 实验设计：小剂量LAAM(99 mg/wk)，辅助性偶发 管理程序；小剂量LAAM(99 mg/wk)，不含附件 应急管理程序；大剂量LAAM(330毫克/周) 附加应急管理程序；和大剂量LAAM(330毫克/周) 没有附加的应急管理程序。的持续时间 研究为期24周，LAAM每周三次 (MWF)基准。受试者在1-3周内被引入LAAM，然后 维持其分配的维持量(99毫克/周或330毫克/周) 一直到第24周。在维护期间，周五的剂量为1.3倍 比周一和周三的剂量更大。在结束时， 研究表明，受试者在4周内接受LAAM戒毒治疗。 对于应急管理程序组中的那些人，每个人都没有毒品 提交尿液将产生一张价值一定货币价值的代金券 连续无药排尿(1-12周)或CT检查的这一比例会增加 价值1美元的州彩票(第13-24周)。代金券可以 在下列时间内随时交换双方商定的商品和服务 这项研究。未分配给应急管理程序的对象 将收到货币代金券(第1-12周)或彩票(第13-13周) 24)根据轭控制计划(即，不视情况而定 非法戒毒)。结果措施将包括：1)治疗 保留，2)非法药物使用，3)自我报告的不良反应和阿片类药物 戒断症状，以及4)心理社会功能。影响预后的因素 (即性、创伤后应激障碍和抑郁症)，也会 接受与治疗结果相关的检查。这些发现将有助于 在制定更有效的策略来治疗患有 可卡因和阿片类药物的联合依赖。