Naltrexone for Heavy Drinking in Young Adults
Condition: Alcohol Consumption; Alcoholic Intoxication; Alcoholism; Alcohol-induced Disorders
MeSH terms: Alcoholism; Alcoholic Intoxication; Alcohol-Induced Disorders; Alcohol Drinking
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, 140 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.
    

Detailed description: 
      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.
    

Intervention name(s): BASICS counseling; naltrexone; placebo naltrexone
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): 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.; 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.; Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks.
Other intervention name(s): brief counseling; brief intervention; ReVia; Depade
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: heavy episodic drinking; young adults; naltrexone; BASICS counseling; alcohol-related consequences; double-blind trial; randomized clinical trial