search
Back to results

Post-Treatment Effects of Naltrexone

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
naltrexone (Revia)
broad spectrum treatment
motivational enhancement therapy
Sponsored by
Indiana University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Psychiatric Research, Indiana University School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 6, 2000
Last Updated
May 11, 2010
Sponsor
Indiana University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00006449
Brief Title
Post-Treatment Effects of Naltrexone
Official Title
Post-Treatment Effects of Naltrexone
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Indiana University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
Double
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
naltrexone (Revia)
Intervention Type
Behavioral
Intervention Name(s)
broad spectrum treatment
Intervention Type
Behavioral
Intervention Name(s)
motivational enhancement therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Institute of Psychiatric Research, Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Post-Treatment Effects of Naltrexone

We'll reach out to this number within 24 hrs