COMBINING BEHAVIORAL TREATMENTS WITH AGONIST MAINTENANCE

行为治疗与激动剂维持相结合

• 批准号: 2122624
• 负责人: Richard S Schottenfeld
• 金额: $ 53.99万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-30 至 1998-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2122624
• 关键词: behavioral medicine; buprenorphine; clinical trials; cocaine; community health services; drug abuse; drug abuse chemotherapy; drug administration rate /duration; human subject; human therapy evaluation; methadone; patient care management; reinforcer

This proposal compares daily agonist maintenance on either Buprenorphine 12 mg SL or Methadone 65 mg PO when combined with a manual guided treatment emphasizing either a community reinforcement approach (CRA) alone or CRA plus contingency management (CM) for the treatment of concurrent opioid and cocaine dependence. While there is a compelling need to develop buprenorphine as an alternative to methadone for agonist maintenance treatment of opioid dependence, neither agent is particularly effective for treating concurrent cocaine dependence. CRA combined with CM has shown great promise as treatment for cocaine dependence without concurrent opioid dependence, and we are interested in replicating and extending the generalizability of this approach to an inner city setting with patients dependent on both opioids and cocaine treated in an agonist maintenance program. Our primary aims in this 26 week clinical trial and six month follow-up are 1) to evaluate whether CRA with CM is more effective overall than CRA without CM in reducing illicit opioid and cocaine use; and 2) to compare the efficacy of maintenance on buprenorphine to methadone, when maintenance is combined with CRA with or without CM. Subjects with concurrent opioid and cocaine dependence (N= 168) will be randomly assigned to treatment condition, using an urn randomization technique to assure balanced cells with regard to important baseline characteristics. Medications will be administered in a double blind, double dummy design. Behavioral treatments will be administered by experienced clinicians who wiIl be systematically trained and supervised throughout the study. Primary outcome measures include reduction in opioid and cocaine use, as assessed by three times per week urine toxicology testing during the 26-week trial. Additional outcome measures include retention in treatment and self-report measures of reductions in drug use and improvements in psychosocial functioning, based on weekly self-report and repeated monthly ASI measures. Data analysis will be based on an intention to treat sample. Follow-up assessments at 3 and 6 months after completion of the treatment protocol will allow evaluation of the durability of treatment effects.

这项建议比较了丁丙诺啡或丁丙诺啡的每日激动剂维持 12毫克SL或美沙酮65毫克PO与手动引导联合 强调社区强化方法(CRA)的治疗 单独或CRA加应急管理(CM)治疗 同时存在阿片类药物和可卡因依赖。虽然有迫切的需求 开发丁丙诺啡替代美沙酮作为激动剂 阿片类药物依赖的维持治疗，两种药物都不是特别的 对治疗并发的可卡因依赖有效。CRA与CM相结合 在治疗可卡因依赖方面表现出了巨大的希望 同时存在阿片依赖，我们有兴趣复制和 将这种方法的普适性扩展到市中心环境 同时依赖阿片类药物和可卡因的患者服用激动剂 维护计划。我们的主要目标是在这26周的临床试验和 6个月的随访是1)评估合并CM的CRA是否更多 总体上，CRA在减少非法阿片类药物和 可卡因的使用；和2)比较维持治疗的效果 丁丙诺啡与美沙酮，当维持与CRA合并或 没有CM。并发阿片类药物和可卡因依赖的受试者(N= 168)将被随机分配到治疗条件，使用骨灰盒 随机化技术，以确保重要的细胞平衡 基线特征。药物将分两次给药。 盲目的，双重假人设计。行为治疗将由以下人员实施 有经验的临床医生将接受系统的培训和监督 在整个研究过程中。主要结果指标包括阿片类药物的减少 和可卡因的使用，每周三次尿毒学评估 在为期26周的试验中进行了测试。其他成果衡量标准包括 减少药物使用的治疗保留和自我报告措施 以及基于每周自我报告的心理社会功能的改善 并重复每月的ASI测量。数据分析将基于 意向处理样品。术后3个月和6个月的随访评估 治疗方案的完成将允许对 治疗效果的持久性。