Post-Treatment Effects of Naltrexone

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: NCT00006449
Recruitment Status : Completed
First Posted : November 7, 2000
Last Update Posted : May 12, 2010
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Indiana University

Brief Summary:
The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with two psychotherapies that differ in scope and intensity. The effect of these treatments will be assessed with patients who differ in their psychosocial need and resources at their disposal, and in their level of cravings for alcohol.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: naltrexone (Revia) Behavioral: broad spectrum treatment Behavioral: motivational enhancement therapy Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Post-Treatment Effects of Naltrexone
Study Start Date : September 2000
Study Completion Date : July 2006

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets current diagnosis of alcohol dependence and have been abstinent for a minimum of 3 and maximum of 21 days prior to treatment
  • Must be able to participate in an 18-month outpatient study, and live within a one hour or less commute to treatment facility.
  • Must be fluent in English.
  • Women of childbearing potential must have a negative pregnancy test.

Exclusion Criteria:

  • Severe hepatic disease or a liver function test greater than 4 times normal.
  • Opiate use in the last 14 days or a history of opioid dependence in the past year.
  • Pregnant or lactating females who are not using a reliable method of birth control.
  • Inability to follow medication instructions and safety precautions.
  • Comorbid substance dependence diagnosis in the past 6-months, excluding nicotine or marijuana dependence.
  • Use of medications intended to decrease drinking.
  • Meets criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, major depression.

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): NCT00006449

United States, Indiana
Institute of Psychiatric Research, Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
National Institute on Alcohol Abuse and Alcoholism (NIAAA) Identifier: NCT00006449     History of Changes
Other Study ID Numbers: NIAAADAV12696
R01AA012696 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2000    Key Record Dates
Last Update Posted: May 12, 2010
Last Verified: May 2010

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