COMBINING BEHAVIORAL TREATMENTS WITH AGONIST MAINTENANCE

行为治疗与激动剂维持相结合

• 批准号: 2122623
• 负责人: Richard S Schottenfeld
• 金额: $ 41.6万
• 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 1998-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2122623
• 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.

该提案比较了丁丙诺啡的每日激动剂维持 12 毫克 SL 或美沙酮 65 毫克口服，与手动指导结合使用 强调社区强化方法 (CRA) 的治疗 单独或 CRA 加上应急管理 (CM) 来治疗 并发阿片类药物和可卡因依赖。虽然有迫切的需求 开发丁丙诺啡作为美沙酮激动剂的替代品 阿片类药物依赖的维持治疗，两种药物都不是特别有效 对于治疗并发的可卡因依赖有效。 CRA与CM相结合 已显示出作为治疗可卡因依赖的巨大希望，而无需 并发阿片类药物依赖，我们有兴趣复制和 将这种方法的普遍性扩展到内城环境 依赖阿片类药物和可卡因的患者接受激动剂治疗 维护计划。我们在这个为期 26 周的临床试验中的主要目标是 六个月的随访是 1) 评估 CRA 与 CM 是否更有效 在减少非法阿片类药物方面比没有 CM 的 CRA 总体上更有效 使用可卡因； 2）比较维护的效果 当维持治疗与 CRA 联合使用时，丁丙诺啡改为美沙酮，或 没有CM。同时患有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 随机化技术可确保重要的细胞平衡 基线特征。药物将分两次给药 盲人、双假人设计。行为治疗将由 经验丰富的临床医生将接受系统培训和监督 整个研究过程中。主要结果指标包括减少阿片类药物的使用 和可卡因的使用，通过每周 3 次尿液毒理学评估 在 26 周的试验期间进行测试。其他成果衡量标准包括 坚持治疗和减少药物使用的自我报告措施 根据每周自我报告，心理社会功能得到改善 并重复每月 ASI 测量。数据分析将基于 处理样品的意图。术后3个月和6个月的随访评估 治疗方案的完成将允许评估 治疗效果的持久性。