Post-Treatment Effects of Naltrexone

May 11, 2010 updated by: Indiana University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Institute of Psychiatric Research, Indiana University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

November 6, 2000

First Submitted That Met QC Criteria

November 6, 2000

First Posted (Estimate)

November 7, 2000

Study Record Updates

Last Update Posted (Estimate)

May 12, 2010

Last Update Submitted That Met QC Criteria

May 11, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAADAV12696
  • R01AA012696 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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