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. ? ? ?

National Institute of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Research Project (R01)
Project #
Application #
Study Section
Health Services Research Review Subcommittee (AA)
Program Officer
Fertig, Joanne
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Yale University
Schools of Medicine
New Haven
United States
Zip Code
Bold, Krysten W; Fucito, Lisa M; DeMartini, Kelly S et al. (2017) Urgency traits moderate daily relations between affect and drinking to intoxication among young adults. Drug Alcohol Depend 170:59-65
Bold, Krysten W; Fucito, Lisa M; Corbin, William R et al. (2016) Daily relations among affect, urge, targeted naltrexone, and alcohol use in young adults. Exp Clin Psychopharmacol 24:367-375
Menary, Kyle R; Corbin, William R; Leeman, Robert F et al. (2015) Interactive and Indirect Effects of Anxiety and Negative Urgency on Alcohol-Related Problems. Alcohol Clin Exp Res 39:1267-74
O'Malley, Stephanie S; Corbin, William R; Leeman, Robert F et al. (2015) Reduction of alcohol drinking in young adults by naltrexone: a double-blind, placebo-controlled, randomized clinical trial of efficacy and safety. J Clin Psychiatry 76:e207-13
DeMartini, Kelly S; Leeman, Robert F; Corbin, William R et al. (2014) A new look at risk-taking: using a translational approach to examine risk-taking behavior on the balloon analogue risk task. Exp Clin Psychopharmacol 22:444-52
Jatlow, Peter I; Agro, Ann; Wu, Ran et al. (2014) Ethyl glucuronide and ethyl sulfate assays in clinical trials, interpretation, and limitations: results of a dose ranging alcohol challenge study and 2 clinical trials. Alcohol Clin Exp Res 38:2056-65
Corbin, William R; Zalewski, Suzanne; Leeman, Robert F et al. (2014) In with the old and out with the new? A comparison of the old and new binge drinking standards. Alcohol Clin Exp Res 38:2657-63
Corbin, William R; Scott, Caitlin; Leeman, Robert F et al. (2013) Early subjective response and acquired tolerance as predictors of alcohol use and related problems in a clinical sample. Alcohol Clin Exp Res 37:490-7
Leeman, Robert F; Corbin, William R; Fucito, Lisa M et al. (2013) Predictors of Interest in an Alcohol Reduction Clinical Trial of Naltrexone among Undergraduates. J Addict Res Ther 4:151
DeMartini, Kelly S; Palmer, Rebekka S; Leeman, Robert F et al. (2013) Drinking less and drinking smarter: direct and indirect protective strategies in young adults. Psychol Addict Behav 27:615-26

Showing the most recent 10 out of 20 publications