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Naltrexone for Early 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: NCT00000455
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : June 20, 2011
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
UConn Health

Brief Summary:

Early problem drinkers are prevalent in the United States. Recent controlled trials have shown that brief interventions in the primary care setting can reduce drinking and alcohol-related problems in patients who lack evidence of alcohol dependence.

Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few pharmacotherapy studies have been undertaken with early problem drinkers. This study is an 8-week trial of naltrexone versus placebo, combined with coping skills treatment that either focuses on targeted use of medication or serves as background to daily use of the medication. A total of 160 early problem drinkers recruited through screening in primary care medical settings will be randomly assigned to one of four treatment groups. Followup evaluations will be conducted at the end of treatment and again 3, 6, and 12 months.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: naltrexone Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Targeted Naltrexone for Early Problem Drinkers
Study Completion Date : September 2002

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Limited to early problem drinkers (i.e., those with no more than mild alcohol dependence).
  • Have an average weekly alcohol consumption of greater than or equal to 24 standard drinks for men and 18 standard drinks for women.
  • Able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment.
  • Willing to provide a collateral informant for interviews regarding the patient's drinking during the study.
  • A woman of child-bearing potential must be non-lactating, practicing a reliable method of birth control, and have a negative pregnancy test prior to initiation of treatment.
  • Willing to provide a signed informed consent to participate in the study.

Exclusion Criteria:

  • Have a current clinically significant physical disease or abnormality.
  • Have a serious psychiatric illness.
  • Have a current diagnosis of drug dependence (other than nicotine dependence) or a lifetime diagnosis of opioid dependence.
  • A current diagnosis of alcohol dependence that is moderate or greater in severity or a history of alcohol withdrawal, or recurrent use of alcohol to alleviate alcohol withdrawal symptoms.
  • Used opioids or other psychoactive medications regularly in the month prior to study enrollment.
  • History of hypersensitivity to naltrexone (Revia).

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): NCT00000455

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United States, Pennsylvania
Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
UConn Health
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Responsible Party: Dr. Henry R. Kranzler, University of Pennsylvania Identifier: NCT00000455    
Other Study ID Numbers: NIAAAKRA11062
R01AA011062 ( U.S. NIH Grant/Contract )
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents