A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use

描述(申请人提供)：可卡因滥用是一个无情的公共卫生问题。行为疗法被认为是减少可卡因使用和防止复发的“标准护理”。然而，即使进行了密集的行为干预，可卡因的复吸率也高得令人沮丧(即，60%-95%的患者重新吸毒)。迫切需要新的战略来改善可卡因使用障碍的治疗结果。该项目的总体目标是评估创新的可卡因抑制控制训练程序的可行性、可接受性和初步效果。这一目标将通过进行第一阶段试点试验来实现。可卡因依赖的参与者将被登记并随机接受对可卡因或中性图像的抑制控制训练(N=20/条件)。这项拟议的干预措施，基于可卡因的抑制控制培训，将使用一个创新的计算机程序来提供，该程序教导可卡因滥用者抑制对可卡因或中性线索的预先潜在反应。基本假设是，所提出的程序是可行的，并为参与者所接受。可行性将通过确定登记目标样本所需的时间；适应性随机结果；盲人研究人员的失明维持；参与者出席、完成和遵守研究程序来评估。可接受性将使用治疗可接受性问卷来确定。第二个假设是，接受以可卡因为基础的抑制控制训练的参与者将减少他们的药物使用 与中性表象条件下的同龄人相比，差异程度更大。减少可卡因的使用将通过减少尿液定性分析的阳性尿样和减少尿液定量分析(即酶联免疫吸附试验)确定的苯甲酰ecGonine水平来证明。第三种假设是，与处于中性表象状态的参与者相比，接受以可卡因为基础的抑制控制训练的参与者将表现出更好的抑制控制和神经认知功能。改进的抑制性控制、冲动和认知功能将 使用一系列临床仪器和实验室任务进行演示。拟议的研究具有很高的创新性，因为它将提供关于以可卡因为基础的抑制控制训练的可行性、可接受性、初步效果的关键信息，以减少药物使用和 改善可卡因依赖参与者的抑制控制和神经认知功能。基于可卡因的抑制控制训练也很容易管理(即15分钟)，费用低廉，不需要临床医生管理，并且可以很容易地纳入当前的行为或基于社区的治疗方法，以加强持续戒断，从而迅速影响临床研究和实践。基于可卡因的抑制控制培训计划也可以转换为智能手机，在诊所外进行管理。在诊所外进行培训将允许患者接受更频繁的强化治疗，通过允许他们在需要时接受治疗，进一步改善持续戒断。

DESCRIPTION (provided by applicant): Cocaine abuse is an unrelenting public-health concern. Behavioral therapies are considered the "standard of care" for reducing cocaine use and preventing relapse. However, even with intense behavioral interventions, rates of relapse to cocaine use are discouragingly high (i.e., 60-95% of patients return to drug use). Novel strategies are urgently needed to improve treatment outcomes for cocaine-use disorders. The overarching goal of this project is to assess the feasibility, acceptability and initial efficacy o an innovative cocaine-based inhibitory-control training procedure. This goal will be accomplished through the conduct of a Stage I pilot trial. Cocaine-dependent participants will be enrolled and randomized to receive inhibitory-control training to cocaine or neutral images (N=20/condition). This proposed intervention, cocaine- based inhibitory-control training, will be delivered using an innovative computer program which teaches cocaine abusers to inhibit a pre-potent response to cocaine or neutral cues. The primary hypothesis is the proposed procedures are feasible and acceptable to the participants. Feasibility will be assessed by determining time needed to enroll the target sample; adaptive randomization outcomes; maintenance of blind for blinded study personnel; participant attendance, completion and adherence to study procedures. Acceptability will be determined using a Treatment Acceptability Questionnaire. The secondary hypothesis is that participants receiving cocaine-based inhibitory-control training will reduce their drug use to a greater extent than their counterparts in the neutral-image condition. Reduced cocaine use will be demonstrated by fewer positive-urine samples using qualitative urinalysis and a reduction in levels of benzoylecgonine as determined by quantitative urinalysis (i.e., ELISA). The third hypothesis is that participants receiving cocaine-based inhibitory-control training will show improved inhibitory control and neurocognitive functioning relative to their counterparts in the neutral-image condition. Improved inhibitory control, impulsivity and cognitive functioning will be demonstrated using a battery of clinical instruments and laboratory tasks. The proposed research is highly innovative in that it will provide critical information regarding the feasibilit, acceptability, initial efficacy of cocaine-based inhibitory-control training to reduce drug use and improve inhibitory control and neurocognitive functioning in cocaine-dependent participants. Cocaine-based inhibitory- control training is also easy to administer (i.e., 15 minutes), inexpensive, need not be administered by a clinician, and could easily be incorporated into current behavioral or community-based treatment approaches to enhance sustained abstinence, thereby quickly impacting clinical research and practice. The cocaine-based inhibitory-control training program could also be converted to a smart-phone for administration outside the clinic. Administering training outside of the clinic would allow patients to receive more frequent booster sessions, further improving sustained abstinence by allowing them to be exposed to therapy as needed.