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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00568958 |
In this study, 132 heavy drinking young adults (aged 18-25) will be provided with brief counseling and either naltrexone, a medication that is FDA-approved for the treatment of alcohol dependence, or placebo over the course of 8 weeks. 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.
Condition | Intervention | Phase |
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Alcohol Consumption Alcoholic Intoxication Alcoholism Alcohol-Induced Disorders |
Behavioral: BASICS counseling Drug: naltrexone Drug: matched placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Naltrexone for Heavy Drinking in Young Adults |
Estimated Enrollment: | 132 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | August 2012 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Behavioral: BASICS counseling
Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
Drug: naltrexone
Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks.
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2: Placebo Comparator |
Behavioral: BASICS counseling
Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.
Drug: matched placebo
Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks.
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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.
Ages Eligible for Study: | 18 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Each subject must:
Exclusion Criteria:
No subject may:
Contact: Robert F. Leeman, PhD | (203)974-7373 | robert.leeman@yale.edu |
United States, Connecticut | |
Connecticut Mental Health Center/Yale University School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06519 | |
Principal Investigator: Stephanie S O'Malley, PhD |
Principal Investigator: | Stephanie O'Malley, PhD | Yale University |
Responsible Party: | Yale University School of Medicine ( Stephanie O'Malley, Ph.D., Professor of Psychiatry ) |
Study ID Numbers: | NIAAA_OMALLEY-AA016621, NIH grant AA016621-01 |
Study First Received: | December 4, 2007 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00568958 History of Changes |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board |
heavy episodic drinking young adults naltrexone BASICS counseling |
alcohol-related consequences double-blind trial randomized clinical trial |
Alcohol-Induced Disorders Alcoholic Intoxication Narcotic Antagonists Drinking Behavior Disorders of Environmental Origin Narcotics Alcohol Drinking |
Mental Disorders Alcoholism Naltrexone Substance-Related Disorders Alcohol-Related Disorders Peripheral Nervous System Agents Ethanol |
Alcohol-Induced Disorders Alcoholic Intoxication Narcotic Antagonists Physiological Effects of Drugs Drinking Behavior Disorders of Environmental Origin Alcohol Drinking Pharmacologic Actions Sensory System Agents |
Mental Disorders Therapeutic Uses Alcoholism Naltrexone Substance-Related Disorders Alcohol-Related Disorders Peripheral Nervous System Agents Central Nervous System Agents |