Reinforcement Based Treatment for Pregnant Drug Abusers

描述（由申请人提供）：在NIDA行为治疗发展阶段I和II的支持下，成瘾和妊娠中心的研究人员为吸毒成瘾的孕妇开发并测试了一种强化门诊复发预防方法，即基于强化的治疗（RBT）。RBT是基于社会学习理论的原则，并采用禁欲条件下获得生活技能培训，娱乐治疗，就业准备和安置作为强化日间治疗咨询计划的常规方面。RBT已在四项随机对照试验中进行了测试4 -7，最近的一项试验是在没有资格接受或拒绝接受美沙酮治疗的孕妇中进行的。后一项试验的结果表明，与CAP标准治疗参与者相比，RBT参与者的CAP治疗利用率显著更高（61% v. 21%），海洛因戒断率显著提高（52% v. 29%; 67% v. 20%）和可卡因（48% v. 13%; 56% v. 20%）。目的：此修订后的应用程序是第二阶段的行为发展研究，旨在回答剩余的关键问题之前，传播RBT到更大的治疗社区。这些问题的重点是RBT的强度水平最有效的药物成瘾的孕妇，个人的调解人和主持人，确定哪一个RBT治疗水平是最好的，为哪些病人，和RBT治疗的成本效益。设计图：拟议的研究采用了一种新的方法来进行对照临床试验，序贯多分配随机试验（SMART）设计。受试者（N=300）将首先在治疗开始时随机分配至常规治疗RBT或降低强度RBT。所有受试者将根据其最初两周治疗依从性的评估接受后续随机化。早期不依从的受试者将随机接受相同或更高水平的RBT治疗强度，而早期依从的受试者将随机接受相同或更低水平的治疗强度和范围。主要结果指标包括治疗完成情况和母亲海洛因和可卡因使用情况。次要结局指标包括孕产妇HIV风险行为、其他药物使用和心理社会功能的指标，以及新生儿住院时间、生理出生参数、神经完整性和行为功能的指标。创新与意义：拟议项目的创新之处包括：新奇的区域预算测试、使用先进的SMART模式、应用先进的统计技术和纳入成本效益方法。该项目的意义非常重大，因为它将为以后的第三阶段研究奠定基础，重点是传播吸毒成瘾孕妇的阶梯式护理治疗方案，不仅可以在综合护理诊所实施，而且可以在为这些妇女提供服务的各种社区环境中实施。

DESCRIPTION (provided by applicant): With NIDA Behavioral Treatment Development Stage I and II support, researchers at the Center for Addiction and Pregnancy have developed and tested an intensive outpatient relapse-prevention approach, Reinforcement Based Treatment (RBT), for drug-addicted pregnant women. RBT is based on the principles of social learning theory and employs abstinence-contingent access to life-skills training, recreational therapy, and employment preparation and placement as routine aspects of an intensive day treatment counseling program. RBT has been tested in four randomized controlled trials4-7, with the most recent trial in pregnant patients who did not qualify for or refused methadone treatment as an adjunct to care. Results of this latter trial indicated that RBT participants, as compared to CAP standard care participants, had significantly greater CAP treatment utilization (61% v. 21%) at 3 months and significantly greater rates of abstinence from heroin (52% v. 29%; 67% v. 20%) and cocaine (48% v. 13%; 56% v. 20%) at 3 and 6 months, respectively, post-study entry. Objectives: This revised application is a Stage II behavioral development study designed to answer remaining critical questions necessary before disseminating RBT to the larger treatment community. These questions focus on the levels of intensity of RBT most efficacious for drug-addicted pregnant patients, the individual mediators and moderators that determine which RBT treatment level is best for which patient, and the cost-effectiveness of RBT treatment. Design: The proposed study utilizes a novel approach to conducting a controlled clinical trial, the sequential multiple assignment randomized trial (SMART) design. Participants (N=300) will first be randomized at treatment outset into either treatment-as-usual RBT or a reduced intensity RBT. All participants will receive a subsequent randomization based upon an assessment of their initial two weeks of treatment compliance. Early-non-compliant participants will be randomized to receive either the same or an increased level of RBT treatment intensity while early-compliant participants will be randomized to receive either the same or decreased level of treatment intensity and scope. Primary outcome measures include treatment completion and maternal heroin and cocaine use. Secondary outcome measures include maternal measures of HIV risk behavior, other drug use, and psychosocial functioning and neonatal measures of length of hospitalization, physical birth parameters, neurological integrity, and behavioral functioning. Innovation and Significance: The proposed project's innovation includes: the novelty RBT, use of a cutting- edge SMART model, application of advanced statistical techniques and inclusion of a cost-effectiveness approach. The proposed project's significance is exceedingly high, as it will lay the foundation for later Stage III studies focused on dissemination of stepped care treatment programs for drug-addicted pregnant women that can be implemented not only in comprehensive care clinics but in diverse community settings that provide services to such women.