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Post-Treatment Effects of Naltrexone

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00006449
First received: November 6, 2000
Last updated: May 11, 2010
Last verified: May 2010
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Post-Treatment Effects of Naltrexone

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism
U.S. FDA Resources

Further study details as provided by Indiana University:

Estimated Enrollment: 160
Study Start Date: September 2000
Estimated Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006449

Locations
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)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006449     History of Changes
Other Study ID Numbers: NIAAADAV12696, R01AA012696
Study First Received: November 6, 2000
Last Updated: May 11, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Alcoholism
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 May 16, 2013