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，成瘾和怀孕中心的研究人员已经开发并测试了一种强化门诊预防复发的方法，强化治疗（RBT），用于吸毒的孕妇。RBT是建立在社会学习理论的基础上的，它采用了禁欲条件下的生活技能培训、娱乐治疗、就业准备和安置，作为强化的日常治疗咨询项目的常规方面。RBT已经在四项随机对照试验中进行了测试，最近的试验是在不符合或拒绝美沙酮辅助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参与者在3个月时显著更高的CAP治疗利用率（61%对21%），在研究开始后3个月和6个月时，分别显著更高的海洛因戒断率（52%对29%；67%对20%）和可卡因戒断率（48%对13%；56%对20%）。目的：这项修订后的应用是一项II期行为发展研究，旨在回答在将RBT推广到更大的治疗社区之前必要的剩余关键问题。这些问题集中在对吸毒孕妇最有效的RBT强度水平，决定哪种RBT治疗水平对哪种患者最有效的个体介质和调节因子，以及RBT治疗的成本效益。设计：本研究采用一种新颖的方法进行对照临床试验，即顺序多任务随机试验（SMART）设计。参与者（N=300）将首先在治疗开始时随机分为常规治疗RBT或降低强度RBT。所有参与者将根据他们最初两周治疗依从性的评估接受随后的随机化。早期不依从的参与者将被随机分配接受相同或增加水平的RBT治疗强度，而早期依从的参与者将被随机分配接受相同或降低水平的治疗强度和范围。主要结局指标包括治疗完成情况和孕产妇海洛因和可卡因使用情况。次要结局指标包括孕产妇艾滋病毒风险行为、其他药物使用和社会心理功能的指标，以及新生儿住院时间、身体出生参数、神经完整性和行为功能的指标。创新及意义：建议项目的创新包括：采用新颖的RBT、采用先进的SMART模型、应用先进的统计技术，以及采用成本效益方法。该项目的重要性非常高，因为它将为后期的第三阶段研究奠定基础，这些研究的重点是传播针对吸毒成瘾孕妇的阶梯护理治疗方案，这些方案不仅可以在综合护理诊所实施，还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. PUBLIC HEALTH RELEVANCE: This Stage II development study utilizes a SMART (sequential multiple assignment trial) design to answer remaining critical questions, regarding the levels of intensity of RBT most efficacious for pregnant patients and its cost-efficacy, necessary before disseminating this therapy to the larger treatment community.