Behavioral Strategies to maximixe pharmacotherapy efficacy for Cocaine dependence

减少可卡因使用的治疗方法既有基于假设的生物学机制作用的药理学方法，也有基于行为和认知行为理论的心理学方法。大多数治疗可卡因依赖的药物疗法仍需确认。在这笔赠款的原始资助期间，我们在SAMDRC的研究在确定激动剂药物治疗可卡因依赖的作用方面发挥了关键作用。我们已经证明左旋多巴（L-dopa）沿着卡比多巴可以安全地给药，并且在可卡因依赖的门诊治疗中与安慰剂相比具有明显的疗效。然而，这种药物疗法的最佳使用不太可能取决于给药的行为/环境背景。认知行为方法和应急管理程序是两种基于行为的可卡因成瘾治疗方法，已被经验评估。本研究的目的是确定这两种流行的行为方法，独立或组合，有助于提高一个有前途的新的药理学策略。两项研究将同时进行。研究1将采用随机化、组间、加性研究设计来检验RP和应急管理程序（CMP）的组合可以增强L-多巴/卡比多巴的功效的假设。将比较不同强度的三种治疗条件：（1）仅临床管理（CM）;（2）CM+RP和（3）CM +CMP。将在活性药物和安慰剂给药条件下检查这些治疗条件的增量疗效。总共120名可卡因依赖者的样本将被随机分配到六种治疗条件之一。研究2将参数化评估哪种类型的应急激励，与RP相比，设施激动剂药物治疗的疗效。参与者将接受RP治疗与CMP相结合，CMP的目标是门诊出勤率，药物依从性或可卡因戒断。总共120名可卡因依赖者的样本将被随机分配到六种治疗条件之一。两项研究将同时进行，使用几乎相同的招募、入组和评估程序。治疗组的分配将是随机的，使用随机化技术，以确保可能影响结局的基线特征的平衡分布。将在12周治疗和1年随访期间收集与可卡因相关的标准结局变量（尿液毒理学筛查和患者自我报告）、成瘾问题严重程度、药物依从性和门诊访视出勤率。评估潜在的预后维度，包括可卡因依赖的严重程度、同时饮酒、治疗动机和改变的准备程度，将用于确定与这些明确定义的治疗的最佳结局相关的患者特征。这些研究是我们关于行为疗法与有前途的药物疗法相结合治疗可卡因依赖的研究的直接、逻辑延伸。

Treatments to reduce cocaine use have been both pharmacological based on hypothesized biological mechanisms action, and psychological, based on behavioral and cognitive-behavioral theory. Most pharmacotherapies for cocaine dependence are still in need of confirmation. During the original funding period of this grant, our research at the SAMDRC has been pivotal in identifying the role of agonist medication treatments for cocaine dependence. We have demonstrated that levodopa (L-dopa) along with carbidopa can be safely administered and has discernable efficacy over placebo in the ambulatory treatment of cocaine dependence. The optimal use of this pharmacotherapy, however, is not likely to depend on the behavioral/environment context in which the medication is administered. Cognitive-behavioral approaches and contingency management procedures are two behaviorally based therapies for cocaine addiction that have been empirically evaluated. The purpose of this research is to determine whether these two popular behavioral approaches, independently or combined, serve to enhance a promising new pharmacologic strategy. Two studies will be conducted concurrently. Study 1 will employ a randomized, between groups, additive research design, to test the hypothesis that the combination of RP and Contingency Management Procedures (CMP) can potentiate the efficacy of L- dopa/carbidopa. Three therapy conditions of varying intensity will be compared: (1) clinical management (CM) only; (2) CM+RP, and (3) CM +CMP. The incremental efficacy of these therapy conditions will be examined under active and placebo medication conditions. A total sample of 120 cocaine dependent individuals will be randomly assigned to one of the six treatment conditions. Study 2 will parametrically assess which type of contingent incentive, when compared with RP, facilities the efficacy of agonist pharmacotherapy. Participants will receive RP therapy in combination with a CMP that targets clinic attendance, medication compliance, or cocaine abstinence. A total sample of 120 cocaine dependent individuals will be randomly assigned to one of the six treatment conditions. Both studies will be conducted concurrently, using nearly identical recruitment, intake, and assessment procedures. Assignment to treatment group will be random, using an urn randomizing technique to assure balanced distribution of baseline characteristics that may influence outcome. Standard outcome variables related to cocaine (urine toxicology screens and patient self report), addiction problem severity, medication compliance, and clinic visit attendance will be collected during twelve weeks of treatment and one year follow up. Assessment of potential prognostic dimensions, including severity of cocaine dependence, concurrent alcohol use, motivation for treatment and level of readiness to change, will be used to identify patient characteristics associated with optimal outcome in these well-defined treatments. These studies are direct, logical extensions of our research on the integration of behavior therapy with promising pharmacotherapy for the treatment of cocaine dependence.