Naltrexone for Heavy Drinking in Young Adults

描述（由申请人提供）：NIAAA指定未成年人饮酒为优先研究领域。值得注意的是，问题酒精使用的患病率最高的是18-25岁的年轻人。在这一时期大量饮酒会产生严重的直接和终生的不良后果。行为干预，特别是BASICS（大学生简短酒精筛查和干预），已经开发出来帮助年轻人减少饮酒。虽然这些干预措施是有效的，包括强制接受治疗的大学生和其他没有戒烟动机的人，但效果不大，这表明需要新的方法来加强这些干预措施。一种有希望的策略尚未在年轻人中测试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，即使在没有强烈的内在动机去改变和改变的情况下

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.