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
Intervention: BASICS counseling; naltrexone; placebo naltrexone
Intervention description: 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.
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: heavy episodic drinking; young adults; naltrexone; BASICS counseling; alcohol-related consequences; double-blind trial; randomized clinical trial

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.
    

Eligibility criteria:

        Inclusion Criteria:

        Each subject must:

          1. Be between the ages of 18 and 25;

          2. Report heavy drinking 4 or more times in the past 4 weeks. Heavy drinking is defined
             as 4 or more drinks for women and 5 or more drinks for men on an occasion;

          3. Be able to read English and show no evidence of significant cognitive impairment.

          4. That women of child-bearing potential (i.e., who has not had a hysterectomy, bilateral
             oophorectomy, or tubal ligation), be nonlactating, practicing a reliable method of
             birth control, and have a negative urine pregnancy test prior to initiation of
             treatment.

        Exclusion Criteria:

        No subject may:

          1. Exhibit current, clinically significant physical disease or abnormality on the basis
             of medical history, physical examination, or routine laboratory evaluation, including
             AST or ALT levels greater than 3 times normal or bilirubin levels greater than 110% of
             normal. Individuals with common medical conditions (e.g., asthma, diabetes mellitus,
             thyroid disease) that are adequately controlled and who have a relationship with a
             primary-care practitioner will not be excluded;

          2. Exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe
             major depression, panic disorder, borderline personality disorder, organic mood or
             mental disorders, or substantial suicide or violence risk) by history or psychological
             examination;

          3. Have a current diagnosis of DSM-IV drug dependence other than nicotine, or a lifetime
             history of DSM-IV opiate dependence;

          4. Have a current DSM-IV diagnosis of alcohol dependence that is clinically severe
             defined by a) a history of seizures, delirium, or hallucinations during alcohol
             withdrawal, b) a Clinical Institute Withdrawal Assessment scale (Sullivan et al.,
             1989) score of > 8, c) report drinking to avoid withdrawal symptoms, or d) have had
             prior treatment of withdrawal.

          5. Have used opioids or concomitant therapy with any psychotropic drug in the past month,
             except that subjects who are on a stable dose of a Selective Serotonin Reuptake
             Inhibitor for at least two months for the indications of Major Depressive Disorder,
             Premenstrual Syndrome (PMS), or Premenstrual Dysphoric Disorder (PMDD) will not be
             excluded; SSRIs are allowed due to their safety profile relative to other classes of
             antidepressants.

          6. Have a history of hypersensitivity to naltrexone;

          7. Be considered by the investigators to be an unsuitable candidate for receipt of an
             investigational drug.

          8. The investigators may exclude participants who complete daily questionnaires on less
             than half of the days between intake and treatment.