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想的生物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然需要得到证实。在这笔赠款的最初资助期间，我们在SAMDRC的研究在确定激动剂药物治疗对可卡因依赖的作用方面发挥了关键作用。我们已经证明，在门诊治疗可卡因依赖的过程中，左旋多巴(L-多巴)和卡比多巴是安全的，并且比安慰剂有明显的疗效。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，已经过经验评估。这项研究的目的是确定这两种流行的行为方法，无论是独立的还是联合的，都有助于增强一种有前景的新的药理学策略。两项研究将同时进行。研究1将采用随机、组间、相加的研究设计，以检验RP和应急管理程序的组合可以增强L-多巴/卡比多巴的疗效的假设。将比较三种不同强度的治疗条件：(1)仅临床治疗(CM)；(2)CM+RP；(3)CM+CMP。这些治疗条件的递增疗效将在积极和安慰剂药物条件下进行检验。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中的一种。研究2将参数评估哪种类型的或有激励与RP相比，更有利于激动剂药物治疗的疗效。参与者将接受RP治疗，并结合针对门诊就诊、用药依从性或可卡因戒断的CMP。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中的一种。这两项研究将同时进行，使用几乎相同的招募、录取和评估程序。治疗组的分配将是随机的，使用骨灰盒随机化技术，以确保可能影响结果的基线特征的均衡分布。与可卡因相关的标准结果变量(尿毒学筛查和患者自我报告)、成瘾问题严重程度、用药依从性和门诊就诊次数将在12周的治疗和一年的随访中收集。对潜在预后因素的评估，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中的最佳结果相关的患者特征。这些研究是我们将行为疗法与有希望的药物疗法结合起来治疗可卡因依赖的研究的直接、合乎逻辑的延伸。

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.