Aerobic Exercise to Improve Outcomes of Treatment for Methamphetamine Dependence

描述（由申请人提供）：这项为期五年的研究将收集关于有氧运动治疗洛杉矶Cri-Help住院药物治疗计划中150名寻求治疗的甲基苯丙胺依赖者的疗效数据。在签署知情同意书并满足所有入选/排除要求后，受试者将入组研究，并在约两周的治疗期间照常接受基线评估。随机分组后，受试者将进入运动条件（n=75）或对照（健康教育; n=75）条件，干预持续8周。参加任何一种条件活动（每周三次）的奖励固定为每次10美元。在总共150名参与者中，30名自愿参与者将成为脑成像子研究的一部分。成像子研究的目的是确定与运动对治疗结果的假设影响相关的可能脑机制。该研究的主要目标是严格和全面地确定在住院计划中纳入有氧运动是否改善了治疗结果，即在出院后的前12周和26周随访期间减少甲基苯丙胺的使用，以及与对照组（教育组）相比，运动对健康，精神症状和认知的影响。本研究的目的是：目的1。在MA依赖个体人群中，描述有氧运动干预（“运动”）与健康教育（“教育”）相比对住院药物治疗出院后药物使用的影响。目标二。描述运动对MA依赖住院治疗参与者的MA渴求和负性情感状态（包括焦虑、抑郁、快感缺乏和应激反应）的影响。目标3：描述运动对神经认知功能的影响。目标4。为了描述运动条件下与教育条件下参与者之间健康相关结果的变化。目标5。检查分配到运动组的戒酒MA依赖参与者与教育（对照）组参与者子样本（每组n = 15）相比多巴胺D2/D3受体可用性的变化。目标6。根据干预条件，检查成瘾相关行为的差异（根据ASI-type测量）。迫切需要对治疗甲基苯丙胺使用障碍的战略进行系统评价。因此，本项目响应NIDA的要求（RFA-DA-09-013），开发和评估一种有效的基于运动的成瘾干预措施。 公共卫生相关性：拟议的研究具有相当大的公共卫生意义，因为它将提供关于有氧运动作为甲基苯丙胺依赖干预措施的基本信息，甲基苯丙胺依赖是一个具有广泛影响的严重毒品问题。如果证明有效，该方案可用于治疗成瘾和减少接受治疗的个体中甲基苯丙胺的使用，从而有效地减少药物滥用和相关后果，如犯罪活动、社会混乱和由于甲基苯丙胺使用期间不安全性活动频率增加而导致的艾滋病毒传播/感染风险增加。拟议的项目将确定一个创新的干预方案，以前未经测试的MA依赖个人的临床效用。

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.