Aerobic Exercise to Improve Outcomes of Treatment for Methamphetamine Dependence

描述(申请人提供)：这项为期五年的研究将收集在洛杉矶Cri-Help住宅药物治疗计划中寻求治疗的150人中有氧运动治疗甲基苯丙胺依赖的有效性的数据。在签署同意书并满足所有纳入/排除要求后，参与者将被纳入研究，并像往常一样在大约两周的治疗期间接受基线评估。随机后，参与者将进入运动条件(n=75)或对照(健康教育；n=75)条件，为期8周的干预持续时间。参加任一条件活动(每周三次)的奖励固定为每期10美元。在总共150名参与者中，30名自愿参与者将参与一项脑成像分研究。成像子研究的目的是确定与运动对治疗结果的假想影响相关的可能的大脑机制。这项研究的主要目标是严格和全面地确定在出院后的前12周和26周的随访中，在出院后的前12周和26周的随访中，是否将有氧运动纳入住院计划中，以改善治疗结果，并与干预前/后的对照组(教育组)相比，确定运动对健康、精神症状和认知的影响。这项研究的目的是：1.比较有氧运动干预(“运动”)和健康教育(“教育”)在住院药物治疗出院后的药物使用方面的作用。目的2.研究运动对住院治疗MA依赖者的MA渴求和包括焦虑、抑郁、快感缺乏和应激反应在内的负性情绪状态的影响。目的3.研究运动对神经认知功能的影响。目的4.与教育条件下的参与者相比，研究锻炼条件下参与者在健康相关结果上的差异。目的5.检测被分配到运动组的戒断性MA依赖参与者与教育(对照组)参与者(每组15人)的多巴胺D2/D3受体可用性的变化。目的6.检验不同干预条件下成瘾相关行为(ASI-type量表)的差异。迫切需要对治疗甲基苯丙胺使用障碍的战略进行系统评估。因此，该项目响应了NIDA的要求(RFA-DA-09-013)，以开发和评估有效的运动成瘾干预措施。 公共卫生相关性：拟议的研究具有相当大的公共卫生意义，因为它将提供有氧运动作为干预甲基苯丙胺依赖的基础信息，甲基苯丙胺依赖是一个影响广泛的严重药物问题。如果证明有效，该议定书可有助于治疗成瘾和减少接受治疗的个人使用甲基苯丙胺，从而有效地减少药物滥用和相关后果，如犯罪活动、社会破坏和由于服用甲基苯丙胺期间不安全性行为频率增加而增加的艾滋病毒传播/感染风险。这项拟议的项目将确定一种创新的干预方案的临床实用性，该方案以前未在MA依赖者身上进行测试。

DESCRIPTION (provided by applicant): This five-year study will assemble data on the efficacy of aerobic exercise for the treatment of methamphetamine dependence in a population of 150 individuals seeking treatment at Cri-Help residential drug treatment program in Los Angles. After signing consent and satisfying all inclusion/exclusion requirements, participants will be enrolled into the study and undergo baseline assessments during approximately two weeks of treatment as usual. After randomization, participants will enter the Exercise condition (n=75) or the control (Health Education; n=75) condition for an 8-week intervention duration. Incentives for participation in either condition activity (thrice weekly) are fixed at $10 per session. Of the 150 total participants, 30 voluntary participants will be part of a brain imaging substudy. The objective of the imaging substudy is to determine possible brain mechanisms associated with hypothesized effects of exercise on treatment outcomes. The primary goal of the study is to rigorously and comprehensively determine whether inclusion of a aerobic exercise within a residential program improves treatment outcomes in terms of reduced methamphetamine use during the first 12 weeks post discharge and 26 week follow up, as well as to characterize effects of exercise on health, psychiatric symptoms and cognition compared to the control (education) group pre/post intervention. Aims of the study are: Aim 1. To characterize effects of an aerobic exercise intervention ("Exercise") compared to health education ("Education") in terms of drug use after discharge from residential drug treatment in a population of MA- dependent individuals. Aim 2. To characterize effects of Exercise on MA craving and negative affective states including anxiety, depression, anhedonia, and stress reactivity among participants in residential treatment for MA dependence. Aim 3. To characterize effects of Exercise on neurocognitive functioning. Aim 4. To characterize variations in health-related outcomes among participants in the Exercise condition compared with those in the Education condition. Aim 5. To examine changes in dopamine D2/D3 receptor availability in abstinent MA-dependent participants assigned to an Exercise group compared to a subsample of participants in an Education (control) group (n = 15 per group). Aim 6. To examine differences in addiction-related behaviors (per ASI-type measures) according to intervention condition. There is a critical need for systematic evaluation of strategies for treating methamphetamine use disorders. Thus, this project responds to NIDA request (RFA-DA-09-013) to develop and evaluate an effective exercise-based intervention for addiction. PUBLIC HEALTH RELEVANCE: The proposed research is of considerable public health significance in that it will provide foundational information on aerobic exercise as an intervention for methamphetamine dependence, a serious drug problem with extensive impacts. If proven effective, the protocol could be useful in treating addiction and in reducing methamphetamine use among treated individuals, thereby efficiently reducing drug abuse and related consequences such as criminal activity, social disruption, and elevated risk of HIV transmission/infection due to increased frequency of unsafe sexual activities while on methamphetamine. The proposed project will determine clinical utility of an innovative intervention protocol previously untested in MA-dependent individuals.