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: 2897977
• 负责人: Alison Oliveto
• 金额: $ 42.12万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-09-01 至 2001-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2897977
• 关键词: behavior modification; behavioral /social science research tag; clinical research; cocaine; combination therapy; depression; drug abuse; drug abuse therapy; drug administration rate /duration; drug withdrawal; functional ability; human subject; human therapy evaluation; interview; methadylacetate; opiate alkaloid; posttraumatic stress disorder; sex behavior; urinalysis

DESCRIPTION: (Applicant's Abstract) 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 proposes 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 experimental 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 than 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 group, 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 monetary voucher with a fixed value (weeks 13-24). Subjects not assigned to the contingency management procedure will receive monetary vouchers (weeks 1-24) according to a yoked-control schedule (that is, not contingent upon illicit drug abstinence). Vouchers can be exchanged for mutually agreed upon goods and services at any time during the study. Outcome measures will include treatment retention, 2) illicit drug use, 3) self-reported adverse and opioid withdrawal symptoms, and 4) psychosocial functioning. Follow-up interviews at nine months and/or one year post-study entry will be conducted to determine status post-treatment. Prognostic factors (i.e., sex, post-traumatic stress disorder, and depression), will also be examined in relation to treatment outcome and post-treatment status. These Findings will assist in developing more effective strategies in treating individuals with combined cocaine and opioid dependence.

描述：（申请人摘要） 虽然左旋-α-乙酰美沙酮（LAAM），美沙酮的衍生物， 已成功用作阿片类药物中美沙酮维持的替代品 成瘾者，其对同时滥用阿片类药物和可卡因的影响尚未得到 确定。 因此，本研究建议检查 低剂量和高剂量LAAM维持阿片类药物和可卡因使用， 阿片类药物依赖的可卡因滥用者 此外，由于应急管理 这些程序在减少可卡因使用方面取得了一些成功， 可卡因滥用者 这项研究还建议审查 有无应急管理的临床疗效 针对非法药物使用的程序。 一百六十名男性和女性 阿片类药物依赖可卡因滥用者将按性别分层， 根据2x2实验， 设计：低剂量LAAM（99 mg/周）联合辅助应急管理 程序;低剂量LAAM（99 mg/周），无辅助应急管理 程序;高剂量LAAM（330 mg/周）联合辅助应急管理 和高剂量LAAM（330 mg/周），无辅助应急 管理程序。 研究持续时间为24周， LAAM每周三次（MWF）。 受试者 在第1-3周期间导入LAAM，然后维持其分配的 维持剂量（99 mg/周或330 mg/周）至第24周。 期间 维持期，周五剂量将是周一剂量的1.3倍， 周三剂量。 在研究结束时，受试者接受 在4周内接受LAAM排毒。 对于那些在应急 管理程序组，提交的每一份无药物尿液将导致 一种价值一定的货币价值的凭证，连续增加 无药物尿液（第1-12周）或具有固定价值的货币券 （第13-24周）。 未分配至应急管理的受试者 程序将收到货币券（第1-24周）根据一个 联动控制时间表（即不取决于非法药物 禁欲）。 交换机可以交换双方商定的货物， 在研究期间随时提供服务。 结果指标将包括 治疗保留，2）非法药物使用，3）自我报告的不良反应， 阿片类药物戒断症状; 4）心理社会功能。 后续行动 入学后九个月和/或一年进行面试 以确定治疗后的状态。 预后因素（即，性， 创伤后应激障碍和抑郁症），也将在 与治疗结果和治疗后状态的关系。 这些发现 将有助于制定更有效的策略， 可卡因和阿片类药物依赖