Naltrexone for Heavy Drinking in Young Adults

纳曲酮治疗年轻人酗酒

• 批准号: 7921478
• 负责人: STEPHANIE S O'MALLEY
• 金额: $ 63.61万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7921478
• 关键词: Adoption; Adult; Affect; Age; Alcohol abuse; Alcohol consumption; Alcohol dependence; Alcohols; Area; Behavior Therapy; Behavioral; Blood alcohol level measurement; Brief Alcohol Screening and Intervention for College Students; Commit; Counseling; Data; Dose; Double-Blind Method; Educational process of instructing; Frequencies; Goals; Healthcare; Heavy Drinking; High Prevalence; Individual; Intervention; Intoxication; Life; Measures; Mediating; Mediator of activation protein; Motivation; Naltrexone; Narcotic Antagonists; National Institute on Alcohol Abuse and Alcoholism; Persons; Pharmaceutical Preparations; Placebo Control; Placebos; Population; Randomized; Reporting; Research; Research Priority; Risk; Testing; adverse outcome; alcohol abstinence; alcohol abuse therapy; alcohol cue; alcohol involvement; alcohol related consequences; alcohol response; base; brief intervention; college; craving; design; double-blind placebo controlled trial; drinking; effective intervention; efficacy testing; emerging adulthood; experience; high risk; individualized feedback; novel strategies; problem drinker; response; skills; treatment duration; treatment effect; treatment response; underage drinking; university student; young adult

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.

描述（由申请人提供）：NIAAA将未成年人饮酒指定为优先研究领域。值得注意的是，在18-25岁的年轻人中，酒精使用问题的患病率最高。在此期间发生的大量饮酒可能会带来重要的直接和终身不利后果。已经开发了行为干预措施，特别是基础知识（对大学生进行简短的饮酒和干预），以帮助年轻人减少饮酒。尽管这些干预措施是有效的，包括大学生要求接受治疗，而其他人则停止饮酒的动力很小，但效果尺寸适中，这表明需要采用新的方法来增强这些干预措施。在年轻人中尚待测试的一种有希望的策略是使用鸦片拮抗剂纳曲酮。在其他研究中，纳曲酮已被证明可以减少消耗的酒精量，即使没有强大的内部动机改变和 在寻求治疗的问题饮酒者中，降低任何大量饮酒的频率。 因此，我们建议进行为期8周的双盲安慰剂对照试验，以测试132名18-25岁年轻人大量饮用的年轻人基础 +纳曲酮的综合功效。将使用一种新的策略来管理低剂量纳曲酮，其中每天的给药将与有针对性的剂量结合使用，以期预期高危情况。主要的假设是，与每日 +靶向安慰剂相比，每日 +靶向纳曲酮将导致重量和任何饮酒的频率降低。为了增强我们能够评估纳曲酮对饮酒影响的敏感性，在治疗期间将获得每日评分。除了基于消耗的饮料数量的传统措施外，这些都将使我们能够检查替代酒精参与度的替代措施（例如，主观中毒，估计的血液酒精水平）。这些数据还将用于检查治疗反应的潜在介体（例如，渴望，酒精的主观影响），以便更好地了解纳曲酮的影响。随机分组后的3、6和12个月，将检查治疗效果的持久性。证明纳曲酮在该人群中的疗效将提供由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保健环境所需的基本信息。