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: 6237986
• 负责人: Alison Oliveto
• 金额: $ 12.03万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-01 至 1998-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6237986
• 关键词: 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.

虽然左旋-α-乙酰美沙酮（LAAM），美沙酮的衍生物， 已成功用作美沙酮维持疗法的替代药物， 阿片类药物成瘾者，其对同时滥用阿片类药物和可卡因的影响没有 已查明。 因此，本研究建议检查临床 低剂量和高剂量LAAM维持治疗对阿片类药物和可卡因使用疗效 阿片类药物依赖的可卡因滥用者。 此外，由于应急 管理程序在减少 可卡因滥用者的可卡因使用，这项研究还提出， 检查是否存在偶然性的临床疗效 针对非法药物使用的管理程序。 一百六十男 和女性阿片类药物依赖可卡因滥用者将按性别分层， 根据2x2随机分配至4个治疗组之一 实验设计：低剂量LAAM（99 mg/wk）联合辅助应急 管理程序;低剂量LAAM（99 mg/周），无辅助治疗 应急管理程序;高剂量LAAM（330 mg/周）， 辅助应急管理程序;和高剂量LAAM（330 mg/周） 没有附加的应急管理程序。 的持续时间 研究将持续24周，每周三次给予LAAM， (MWF)基础 受试者在第1 - 3周期间被引导进入LAAM，然后 维持分配的维持剂量（99 mg/周或330 mg/周） 第24周 在维持期间，周五剂量将是 比星期一和星期三的剂量更大。 结束时 在一项研究中，受试者在4周的时间内经历LAAM的解毒。 对于那些在应急管理程序组，每个药物免费 提交的尿液将导致价值一定的货币价值的凭证 连续无药物尿液（第1 - 12周）或CT 价值1美元的州彩票（第13 - 24周）。 折扣提供将立即 交换双方同意的商品和服务，在任何时候， 书房 未分配至应急管理程序的受试者 将收到货币券（第1 - 12周）或彩票（第13 - 14周）。 24)根据轭控制时间表（即，不取决于 非法药物戒断）。 结果指标将包括：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; 4）心理社会功能。 预后因素 (i.e.,性，创伤后应激障碍和抑郁症），也将 检查与治疗结果的关系。 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混合依赖