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

描述（由申请人提供）：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预防复发的“标准护理”。然而，即使有强烈的行为干预，可卡因使用的复发率也高得令人沮丧（即，60-95%的患者会重新使用药物）。迫切需要新的策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一种创新的可卡因毒品控制培训程序的可行性、可接受性和初步疗效。这一目标将通过开展第一阶段试点试验来实现。可卡因依赖参与者将被招募并随机接受可卡因或中性图像的药物对照训练（N=20/条件）。这项拟议的干预措施，基于可卡因的毒品控制训练，将使用一种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pre-potent反应。主要假设是所提出的程序是可行的，并为参与者所接受。将通过确定入组目标样本所需的时间;适应性随机化结局;设盲研究人员的盲态维持;受试者出勤、完成和遵守研究程序来评估可行性。将使用治疗可接受性问卷确定可接受性。第二个假设是，接受可卡因为基础的药物控制培训的参与者将减少他们的药物使用， 比它们在中性图像条件下的对应物更大的程度。可卡因使用的减少将通过使用定性尿分析的阳性尿样减少和通过定量尿分析测定的苯甲酰爱贡宁水平降低来证明（即，ELISA）。第三个假设是，接受可卡因为基础的神经控制训练的参与者将显示出改善的抑制控制和神经认知功能相对于他们的同行在中性图像条件。改善抑制控制，冲动和认知功能， 使用一系列临床仪器和实验室任务进行演示。拟议的研究具有高度的创新性，因为它将提供关于以可卡因为基础的毒品控制培训在减少毒品使用方面的可行性、可接受性、初步功效以及 改善可卡因依赖参与者抑制控制和神经认知功能。基于可卡因的抑制控制训练也易于管理（即，15分钟），便宜，不需要由临床医生管理，并且可以很容易地结合到当前的行为或基于社区的治疗方法中，以增强持续的禁欲，从而迅速影响临床研究和实践。基于可卡因的药物控制培训计划也可以转换为智能手机，用于诊所外的管理。在诊所外进行培训将使患者能够接受更频繁的强化治疗，通过允许他们根据需要接受治疗来进一步改善持续禁欲。

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.