Exercise as a Behavioral Treatment for Cocaine Dependence

描述（由申请人提供）：可卡因依赖性问题仍然是一个主要的医学、社会和法律的问题，迫切需要一种广泛有效的治疗方法。数十种药物已经在临床试验中进行了评估，尽管做出了这些努力，但没有一种药物获得FDA批准作为可卡因依赖的治疗方法。行为干预，如认知行为疗法，已经适度有效，表明非药物治疗方法值得额外考虑。最近的数据表明，适度的体育锻炼可以减少对香烟的渴望，改善人类的认知功能。这些数据与啮齿类动物的几份报告相吻合，这些报告表明运动（即，车轮运行）减少可卡因自我管理，虽然运动对可卡因使用的影响在人类还没有调查。有趣的是，运动已被证明对人类有强化作用，这可能是其作为成瘾治疗的潜在功效。我们提出了一个安慰剂对照，受试者之间的设计，以评估运动对改善健身，可卡因的使用和对可卡因的渴望的影响。鉴于现有数据显示运动对吸烟有益，我们还将监测吸烟和尼古丁渴望的变化作为阳性对照。具体目标包括：1）评估运动（跑步与步行，每次30分钟，每周3次，连续4周）与安慰剂（相同时间和持续时间的坐姿）对基本健康指标的影响; 2）评估运动对可卡因和尼古丁使用和渴望的客观和主观指标的影响。所有参与者将是符合DSM当前可卡因和尼古丁依赖标准的成年人，他们正在寻求可卡因成瘾治疗。计算机认知行为疗法（CBT）将是提供给所有参与者的标准治疗。还将利用应急管理平台鼓励出勤（而不是禁欲）。运动课程将在NordicTrack Elite 9500 PRO跑步机上进行，所有体力活动课程期间都将有医生或执业护士在场。该申请代表了一项重要的研究工作，具有相当大的公共卫生意义，因为它将建立一个评估运动对可卡因依赖者渴望和使用可卡因和尼古丁的影响的计划。 公共卫生相关性：本申请描述了一项安慰剂对照的受试者间研究，以评估运动对可卡因依赖者改善健身、可卡因使用和对可卡因渴望的影响。

DESCRIPTION (provided by applicant): The problem of cocaine dependence remains a major medical, social, and legal concern, and there is a pressing need for a broadly effective treatment approach. Dozens of medications have been evaluated in clinical trials and, despite these efforts, not one has gained FDA approval as a treatment for cocaine dependence. Behavioral interventions, such as cognitive behavioral therapy, have been moderately effective, indicating that non-pharmacological treatment approaches warrant additional consideration. Recent data suggest that moderate physical exercise attenuates cravings for cigarettes and improves cognitive functioning in humans. These data coincide with several reports in rodents showing that exercise (i.e., wheel running) reduced cocaine self-administration, though the effects of exercise on cocaine use in humans has not been investigated. Of interest, exercise has been shown to be reinforcing in humans, and this may account for its potential efficacy as an addiction treatment. We propose a placebo-controlled, between-subjects design to evaluate the effects of exercise on improved fitness, cocaine use, and craving for cocaine. Given existing data showing beneficial effects of exercise on cigarette smoking, we will also monitor changes in smoking and craving for nicotine as a positive control. The Specific Aims include: 1) To evaluate the effects of exercise (running vs. walking 30 min per session, 3 times per week, over 4 consecutive weeks) versus placebo (sitting for the same period of time and duration) on basic fitness measures; 2) To evaluate the effects of exercise on objective and subjective measures of cocaine and nicotine use and craving. All participants will be adults who meet DSM criteria for current cocaine- and nicotine-dependence, who are seeking treatment for their cocaine addiction. Computerized cognitive behavioral therapy (CBT) will be the standard treatment provided to all participants. A platform of contingency management will also be used to encourage attendance (not abstinence). Exercise sessions will be performed on a NordicTrack Elite 9500 PRO Treadmill, and a physician or nurse practitioner will be present during all physical activity sessions. This application represents an important research effort with considerable public health significance in that it will establish a program for evaluating the effects of exercise on craving and use of cocaine and nicotine in cocaine-dependent individuals. PUBLIC HEALTH RELEVANCE: This application describes a placebo-controlled, between-subjects study to evaluate the effects of exercise on improved fitness, cocaine use, and craving for cocaine in cocaine-dependent individuals.