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Use of Naltrexone in a Clinical Setting

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
naltrexone (Revia)
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets criteria for alcohol dependence (within the past 3 months). Meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse. Must be able to provide an informed consent. Consent to random assignment and be willing to commit to possible medication treatment and research follow-up. Must be eligible for treatment at the Dorchester Alcohol and Drug Commission. Exclusion Criteria: Meets criteria for opiate dependence. Clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion. Hepatocellular disease. Women who are pregnant, nursing, or not practicing an effective means of birth control. Currently being prescribed naltrexone. Known sensitivity or allergy to naltrexone.

Sites / Locations

  • Center for Drug and Alcohol Programs, Medical University of South Carolina

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000445
Brief Title
Use of Naltrexone in a Clinical Setting
Official Title
Effectiveness of Naltrexone in a Community Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2003
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacademic setting. A followup period of 12 months is included. The effect on service utilization and the cost of the addition of naltrexone to treatment services for alcohol dependence also will be assessed. The study will expand existing research concerning the effectiveness of naltrexone in clinical trials versus a clinical setting.

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
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
naltrexone (Revia)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets criteria for alcohol dependence (within the past 3 months). Meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse. Must be able to provide an informed consent. Consent to random assignment and be willing to commit to possible medication treatment and research follow-up. Must be eligible for treatment at the Dorchester Alcohol and Drug Commission. Exclusion Criteria: Meets criteria for opiate dependence. Clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion. Hepatocellular disease. Women who are pregnant, nursing, or not practicing an effective means of birth control. Currently being prescribed naltrexone. Known sensitivity or allergy to naltrexone.
Facility Information:
Facility Name
Center for Drug and Alcohol Programs, Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Use of Naltrexone in a Clinical Setting

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