Naltrexone for Heavy Drinking in Young Adults

描述(申请人提供)：NIAAA已将未成年人饮酒列为优先研究领域。值得注意的是，问题酒精使用的最高流行率是在18-25岁的年轻人中。在此期间大量饮酒可能会产生严重的直接和终生不良后果。为了帮助年轻人减少饮酒，已经开发了行为干预措施，特别是基础知识(针对大学生的简短酒精筛查和干预)。尽管这些干预措施是有效的，包括强制要求大学生接受治疗，以及其他缺乏戒酒动机的人，但效果不大，这表明需要新的方法来加强这些干预措施。一种尚未在年轻人身上测试的有希望的策略是使用阿片类拮抗剂纳曲酮。在其他研究中，纳曲酮已被证明可以减少饮酒量，即使在缺乏强烈的内在改变动力的情况下也是如此。 减少寻求治疗的问题饮酒者酗酒和酗酒的频率。 因此，我们建议进行一项为期8周的双盲安慰剂对照试验，以测试132名18-25岁酗酒的年轻人服用基础药物+纳曲酮的联合疗效。将使用一种新的策略来管理低剂量的纳曲酮，在这种策略中，将结合每日剂量和预期的高风险情况下的靶向剂量。主要假设是，与每日+靶向安慰剂相比，每日+靶向纳曲酮将导致重度饮酒和任何饮酒频率的更大减少。为了提高我们评估纳曲酮对饮酒影响的敏感度，我们将在治疗期间获得每日评级。这些将使我们能够检查酒精参与的其他衡量标准(例如，主观醉酒报告、估计的血液酒精水平)，以及基于饮品消费数量的传统衡量标准。这些数据还将用于检查治疗反应的潜在中介因素(例如，酒精的渴望和主观影响)，以便更好地了解纳曲酮的效果。治疗效果的持久性将在随机分组后的3、6和12个月进行检查。纳曲酮在这一人群中的有效性证明将为大学咨询中心和其他致力于降低年轻人酗酒风险的医疗机构采用纳曲酮提供必要的信息。

DESCRIPTION (provided by applicant): NIAAA has designated underage drinking as a priority research area. Of note, the highest prevalence of problem alcohol use is among young adults ages 18-25. Heavy drinking that occurs during this period can have important immediate and lifelong adverse consequences. Behavioral interventions, notably BASICS (Brief Alcohol Screening and Intervention for College Students), have been developed to help young adults reduce their drinking. Although these interventions are effective, including with college students mandated to treatment and others with minimal motivation to stop drinking, the effect sizes are modest, suggesting that new approaches are needed to enhance these interventions. A promising strategy yet to be tested in young adults is the use of the opiate antagonist naltrexone. In other research, naltrexone has been shown to reduce the amount of alcohol consumed, even in the absence of strong internal motivation to change, and to reduce the frequency of any and heavy drinking in problem drinkers seeking treatment. Thus we propose to conduct an 8 week double-blind placebo-controlled trial to test the combined efficacy of BASICS + naltrexone in 132 young adults aged 18-25 who drink heavily. A novel strategy will be used for administering low-dose naltrexone, in which daily dosing will be combined with targeted dosing in anticipation of high-risk situations. The main hypotheses are that daily + targeted naltrexone will result in greater reductions in frequency of heavy and any drinking compared with daily + targeted placebo. In order to enhance the sensitivity with which we are able to assess naltrexone's effects on drinking, daily ratings will be obtained during treatment. These will permit us to examine alternative measures of alcohol involvement (e.g., reports of subjective intoxication, estimated blood alcohol levels) in addition to the traditional measures based on number of drinks consumed. These data will also be used to examine potential mediators (e.g., craving, subjective effects of alcohol) of treatment response in order to better understand the effects of naltrexone. The durability of treatment effects will be examined at 3, 6 and 12 months after randomization. Demonstration of the efficacy of naltrexone in this population will provide the essential information needed for its adoption by college counseling centers and other health care settings committed to reducing the risk of heavy drinking in young adults.