Naltrexone for Heavy Drinking in Young Adults

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Naltrexone

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.