Exercise as a Behavioral Treatment for Cocaine Dependence

描述(申请人提供)：可卡因依赖问题仍然是一个主要的医疗、社会和法律问题，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批准用于治疗可卡因依赖。行为干预，如认知行为疗法，一直是适度有效的，这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缓解对香烟的渴望，并改善人类的认知功能。这些数据与在啮齿类动物中的几份报告相吻合，这些报告表明，运动(即轮子跑步)减少了可卡因的自我管理，尽管运动对人类可卡因使用的影响尚未被调查。有趣的是，运动已经被证明对人类有增强作用，这可能解释了它作为一种成瘾治疗的潜在疗效。我们提出了一项安慰剂对照的受试者间设计，以评估锻炼对改善体能、可卡因使用和对可卡因的渴望的效果。鉴于现有数据显示锻炼对吸烟有好处，我们还将监测吸烟和对尼古丁渴望的变化，作为积极的控制措施。具体目标包括：1)评估锻炼(每周3次，连续4周，每次30分钟)和安慰剂(坐着相同时间和持续时间)对基本健康指标的影响；2)评估锻炼对可卡因和尼古丁使用和渴求的客观和主观指标的影响。所有参与者都将是符合DSM目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的治疗。计算机化认知行为治疗(CBT)将是向所有参与者提供的标准治疗。还将使用应急管理平台来鼓励出席(而不是禁欲)。锻炼课程将在NordicTrack Elite 9500专业跑步机上进行，所有身体活动课程都将有一名医生或护士在场。这项申请代表了一项具有相当大公共卫生意义的重要研究工作，因为它将建立一个评估运动对可卡因和尼古丁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：这项应用描述了一项安慰剂对照的受试者间研究，以评估锻炼对改善可卡因依赖者的健康状况、可卡因使用和对可卡因的渴望的效果。

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.