Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention

制定可卡因戒断和预防复发的适应性干预措施

• 批准号: 9028634
• 负责人: JOY Marie SCHMITZ
• 金额: $ 47.63万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9028634
• 关键词: Abstinence; Achievement; Address; Awareness; Behavior Therapy; Behavioral; Carbidopa; Characteristics; Chronic; Cocaine; Cocaine Dependence; Combined Modality Therapy; Counseling; Data; Disease; Dopamine; Drug Addiction; Evidence based intervention; Future; Goals; Health; Heterogeneity; Incentives; Individual; Intervention; Levodopa; Mediating; National Institute of Drug Abuse; Outcome; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Phase; Physicians; Placebos; Procedures; Process; Psychological reinforcement; Psychotherapy; Relapse; Research; Research Priority; Rewards; Staging; Subgroup; Substance Use Disorder; System; Testing; Translating; Urine; Work; addiction; base; clinical decision-making; clinical practice; cocaine use; contingency management; disorder later incidence prevention; drug standard; effective intervention; evidence base; improved; individualized medicine; mindfulness intervention; negative affect; personalized approach; prevent; randomized trial; response; synergism; treatment response; trial design

 DESCRIPTION (provided by applicant): Drug addiction is a chronic, devastating, but treatable disorder, for which there exists a growing armamentarium of evidence-based interventions, including pharmacotherapies and psychotherapies. A core principle of drug addiction treatment, however, states that no single treatment is appropriate for everyone; rather, treatments need to be adjusted based on patient characteristics and response in order to be maximally effective. Ideally, clinicians would identify a sequence of interventions that works best across different stages of addiction treatment, from abstinence initiation to relapse prevention. Adaptive treatment interventions have been used successfully to inform this sequential clinical decision-making process. For cocaine use disorders (CUD), the most potent intervention currently available for initiating abstinence is behavior therapy using contingency management (CM) procedures. Intensive CM has been shown to produce initial cocaine abstinence rates of 40%, unmatched by all other forms of behavioral or pharmacological treatment, making it a prototypical first-line therapy for CUD. Importantly, achievement of initial abstinence predicts future abstinence. For the clinician, these research findings translate into a straightforward question: Can we drive CM response rates even higher with targeted adjunctive interventions? The proposed sequential, multiple assignment, randomized trial (SMART) will provide the data needed to answer this question. First, we will determine whether Acceptance and Commitment Therapy (ACT) in combination with CM increases initial treatment response rates. We hypothesize that four weeks of treatment with ACT+CM will produce higher abstinence rates than initial treatment combining standard Drug Counseling with CM (DC+CM). The hypothesized synergism of ACT+CM on primary treatment mechanisms of experiential avoidance and reward sensitivity, respectively, will be examined. Second, for patients who do not respond to initial treatment, we will examine whether dopamine-targeted pharmacotherapy is an effective augmentation strategy. Specifically, we hypothesize that continued ACT+CM treatment with levodopa-carbidopa augmentation will be most effective in promoting abstinence relative to treatment combinations involving continued DC and/or placebo. Third, for patients who respond to initial treatment, we will assess the relative benefit of continued treatment with ACT+CM, as compared to DC+CM, to prevent relapse. ACT emphasizes goal-directed actions based on values that are intrinsically motivating, and is thereby expected to be a more effective intervention for extending the duration of abstinence following initial treatment with intensive CM. In summary, results from this Stage II (PA-13-078) project should support a Go/No Go decision about further Phase III, confirmatory studies. The primary aims of this project address an important NIDA research priority and have the potential to significantly impact how we tailor treatment of CUD to maximize outcomes.

 描述（由适用提供）：药物成瘾是一种慢性，毁灭性但可治疗的障碍，其中存在着循证干预措施的培训，包括药物治疗和心理治疗措施。但是，药物成瘾治疗的核心原则指出，没有任何人适合所有人。相反，需要根据患者特征和反应来调整治疗，以便最大程度地有效。理想情况下，临床医生将确定一系列干预措施，这些干预措施从戒酒计划到预防中的不同阶段，在不同的成瘾治疗阶段最有效。自适应治疗干预措施已成功地用于告知此顺序临床决策过程。对于可卡因使用障碍（CUD），目前可用于戒酒的最潜在干预措施是使用应急管理（CM）程序的行为治疗。强化CM已被证明可产生40％的最初可卡因的禁欲率，这是所有其他形式的行为或药物治疗无与伦比的，使其成为CUD的典型一线治疗。重要的是，实现最初的禁欲预测未来的戒酒。对于临床，这些研究发现转化为一个直接的问题：我们可以通过针对性的辅助干预措施提高CM响应率更高吗？提出的顺序，多个分配，随机试验（SMART）将提供回答此问题所需的数据。首先，我们将确定接受和承诺疗法（ACT）与CM结合是否会提高初始治疗率。我们假设使用标准药物咨询与CM（DC+CM）相比，用ACT+CM进行四个星期的治疗将产生更高的禁欲率。将研究ACT+CM的假设协同作用在经验回避和奖励灵敏度的主要治疗机制上。其次，对于不反应初始治疗的患者，我们将检查靶向多巴胺的药物治疗是否是一种有效的增强策略。具体而言，我们假设持续ACT+CM治疗左旋多巴 - 卡比多巴的增强将最有效地促进与治疗组合相对于继续DC和/或安慰剂的戒酒。第三，对于对初始治疗做出反应的患者，我们将评估与DC+CM相比，与DC+CM相比，我们将评估持续治疗的相对益处，以防止继电器。 ACT强调了基于基于本质上激励的价值观的目标指导的行动，因此，预计将在使用密集CM初次治疗后延长禁欲的持续时间更有效。总而言之，此阶段II（PA-13-078）项目的结果应支持有关进一步III的GO/NO决定，确认研究。该项目的主要目的旨在解决重要的NIDA研究优先级，并有可能显着影响我们如何量身定制CUD以最大化结果。