Targeted Naltrexone for Problem Drinkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00369408
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : June 20, 2011
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
UConn Health

Brief Summary:
The purpose of this study is to determine whether naltrexone, combined with brief coping skills therapy, is effective in the treatment of heavy drinking.

Condition or disease Intervention/treatment Phase
Alcoholism Alcohol Drinking Alcohol Dependence Drug: Naltrexone Drug: placebo Phase 4

Detailed Description:

This is a 12-week, placebo-controlled trial of naltrexone (50 mg orally) in 163 problem drinkers. Problem drinkers are those individuals whose drinking puts them at risk of a variety of psychosocial and medical problems, including alcohol dependence, but who are not physically dependent on alcohol. They are estimated to comprise up to 20% of the general population. The study employed a factorial design in which the effects of medication (naltrexone vs. placebo), schedule of medication administration (i.e., daily vs. targeted), and the interaction of these factors on drinking behavior were examined. Targeted administration refers to the use of medication to cope with anticipated high-risk drinking situations.

The daily monitoring using interactive voice response technology of mood, desire to drink, perceived self-efficacy, and drinking behavior will make it possible to examine in depth the processes by which the study variables exert their effects. Daily monitoring was performed using automated telephone interviews, with in-person follow-up evaluations conducted at 3 and 6 months post-treatment to provide a measure of the durability of treatment effects.

A pharmacogenetic analysis based on preliminary evidence showing that a functional polymorphism in the gene encoding the mu-opioid receptor (OPRM1) affects response to naltrexone will serve to explore an important source of variation in the response to naltrexone treatment. Exploratory analyses involving other potential genetic moderators of the response to naltrexone, such as the gene encoding the delta opioid receptor (OPRD1), will also be conducted, as will the correlation of genotype data with other phenotypes.

Careful evaluation of the study hypotheses will provide important information on the efficacy and mechanism of the effects of targeted naltrexone in problem drinkers. This study will allow us to model effects across multiple levels of analysis in an effort to understand the psychopharmacological mechanisms underlying the therapeutic effects of naltrexone in problem drinkers and to apply novel genetic findings to understanding the pharmacogenetic mechanisms underlying the therapeutic effects of naltrexone in problem drinkers.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Targeted Naltrexone for Problem Drinkers
Study Start Date : June 2003
Actual Primary Completion Date : August 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
naltrexone (50 mg orally) for 12-week treatment period
Drug: Naltrexone
naltrexone (50 mg orally) for 12-week treatment period; 3 and 6 months post-treatment follow-up
Other Name: ReVia

Placebo Comparator: 2
placebo for 12-week treatment period
Drug: placebo
placebo for 12-week treatment period; 3 and 6 months post-treatment follow-up

Primary Outcome Measures :
  1. Drinking days and heavy drinking days [ Time Frame: 12-week trial; 3 and 6 months post-treatment follow-up ]

Secondary Outcome Measures :
  1. Alcohol-related problems [ Time Frame: 12-week trial; 3 and 6 months post-treatment follow-up ]
  2. Biological measures of alcohol consumption (i.e., serum GGTP and CDT) [ Time Frame: 12-week trial; 3 and 6 months post-treatment follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female outpatients 18-70 years of age.
  • Participants will have an average weekly ethanol consumption of >=24 standard drinks for men, or >=18 standard drinks for women (i.e., substantially in excess of non-hazardous drinking levels).
  • Participants will be able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment.
  • If a woman of child-bearing potential (i.e., who has not had a hysterectomy, bilateral oophorectomy, tubal ligation or who are less than two years postmenopausal), participant must be non-lactating, practicing a reliable method of birth control, and have a negative serum pregnancy test prior to initiation of treatment.
  • Participants will be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels).

Exclusion Criteria:

  • Participants who have a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including total bilirubin elevations of >110% or ALT or AST elevations >300% the upper limit of normal or have a diagnosis of Hepatitis B or C infection or AIDS (given the potential for adverse effects of naltrexone on liver function).
  • Participants who have a serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality states, organic mood or mental disorders, or substantial suicide or violence risk) on the basis of history or psychiatric examination.
  • Participants who have a current Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) diagnosis of drug dependence (other than nicotine dependence) or a lifetime DSM-IV diagnosis of opioid dependence.
  • Participants who have a current DSM-IV diagnosis of alcohol dependence that is clinically severe.
  • Participants who have used opioids or other psychoactive medications regularly in the month prior to study enrollment.
  • Participants who have a history of hypersensitivity to naltrexone.
  • Participants who are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00369408

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Henry R. Kranzler, MD University of Pennsylvania

Publications of Results:
Responsible Party: Henry R. Kranzler, Principal Investigator, University of Pennsylvania Identifier: NCT00369408     History of Changes
Other Study ID Numbers: 03-107-2
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: June 2011

Keywords provided by UConn Health:
Randomized Trial
Medication for Heavy Drinking
Naltrexone Treatment
Daily vs. Targeted Administration

Additional relevant MeSH terms:
Alcohol Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents