Targeted Naltrexone for Problem Drinkers

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00369408
First received: August 24, 2006
Last updated: June 17, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Alcoholism
Alcohol Drinking
Alcohol Dependence
Drug: Naltrexone
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Targeted Naltrexone for Problem Drinkers

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Drinking days and heavy drinking days [ Time Frame: 12-week trial; 3 and 6 months post-treatment follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alcohol-related problems [ Time Frame: 12-week trial; 3 and 6 months post-treatment follow-up ] [ Designated as safety issue: No ]
  • Biological measures of alcohol consumption (i.e., serum GGTP and CDT) [ Time Frame: 12-week trial; 3 and 6 months post-treatment follow-up ] [ Designated as safety issue: No ]

Enrollment: 163
Study Start Date: June 2003
Study Completion Date: March 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369408

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Henry R. Kranzler, MD University of Pennsylvania
  More Information

Publications:
Responsible Party: Henry R. Kranzler, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00369408     History of Changes
Other Study ID Numbers: 03-107-2, NIAAA-KRA-P50-03510
Study First Received: August 24, 2006
Last Updated: June 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Connecticut Health Center:
Randomized Trial
Medication for Heavy Drinking
Naltrexone Treatment
Daily vs. Targeted Administration

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014