Naltrexone for Heavy Drinking in Young Adults

描述（由申请人提供）：NIAAA已指定未成年人饮酒作为优先研究领域。值得注意的是，问题酒精使用率最高的是18-25岁的年轻人。在此期间发生的大量饮酒可能会产生重要的直接和终身不良后果。行为干预，特别是BASICS（大学生酒精筛查和干预），已经开发出来，以帮助年轻人减少饮酒。虽然这些干预措施是有效的，包括大学生强制治疗和其他最小的动机停止饮酒，效果大小是适度的，这表明需要新的方法来加强这些干预措施。一个有希望的战略尚未在年轻人中进行测试是使用阿片拮抗剂纳洛酮。在其他研究中，纳洛酮已被证明可以减少饮酒量，即使在缺乏强烈的内在动机的情况下也可以改变， 减少寻求治疗的问题饮酒者的酗酒频率。 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BASICS +纳洛酮在132名18-25岁重度饮酒的年轻人中的联合疗效。一种新的策略将用于管理低剂量纳洛酮，其中每日剂量将与预期的高风险情况下的靶向剂量相结合。主要假设是，与每日+靶向安慰剂相比，每日+靶向纳洛酮将导致重度和任何饮酒频率的更大降低。为了提高我们能够评估纳洛酮对饮酒影响的灵敏度，将在治疗期间获得每日评级。这将使我们能够检查酒精参与的替代措施（例如，主观中毒报告、血液酒精含量估计值）。这些数据也将用于检查潜在的介质（例如，渴望，酒精的主观影响）的治疗反应，以更好地了解纳洛酮的效果。将在随机化后3、6和12个月检查治疗效果的持久性。证明纳洛酮在这一人群中的疗效将提供大学咨询中心和其他致力于降低年轻人大量饮酒风险的医疗机构采用纳洛酮所需的基本信息。

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.