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

描述（由申请人提供）：可卡因滥用是一个不容忽视的公共卫生问题。行为疗法被认为是减少可卡因使用和防止复发的“标准治疗”。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%的患者重新使用毒品）。迫切需要新的策略来改善可卡因使用障碍的治疗结果。本项目的总体目标是评估一种创新的以可卡因为基础的抑制-控制培训程序的可行性、可接受性和初步效果。这一目标将通过进行第一阶段的试点试验来实现。可卡因依赖的参与者将被招募并随机接受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，即基于可卡因的抑制控制训练，将使用一种创新的计算机程序来传授，该程序教导可卡因滥用者抑制对可卡因或中性线索的前性反应。主要假设是提出的程序是可行的和可接受的参与者。将通过确定招募目标样本所需的时间来评估可行性；自适应随机化结果；盲人研究人员的盲人维护；参与者出席、完成和遵守研究程序。可接受性将使用治疗可接受性问卷来确定。第二个假设是，参与者接受基于可卡因的抑制控制训练将减少他们的药物使用

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.