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Behavioral Therapy Plus Naltrexone for Alcoholism

Primary Purpose

Alcoholism, Alcohol Dependence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
naltrexone (Revia)
cognitive behavior therapy
motivational enhancement therapy
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcoholism, Alcohol Dependence, Naltrexone, Cognitive Behavioral Therapy

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets criteria for alcohol dependence, has not had more than one previous inpatient medical detoxification. Consumes on average five standard drinks per day. Able to maintain sobriety for five days (with or without the aid of detoxification medications) as determined by self-report, collateral report, and breathalyzer measurements. Able to read and understand questionnaires and informed consent. Lives within 50 miles of the study site. Exclusion Criteria: Currently meets criteria for any other psychoactive substance dependency disorder. Ever abused opiates. Used psychoactive substance abuse, except marijuana, within the last 30 days as evidenced by patient report, collateral report, and urine drug screen. Meets criteria for disorders of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder. Meets criteria for dissociate disorder or eating disorders. Has current suicidal or homicidal ideation. Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications. Current use of disulfiram (Antabuse). Clinically significant medical problems that would impair participation or limit medication ingestion. Hepatocellular disease. Sexually active females of child bearing potential who are pregnant, nursing, or who are not using a reliable form of birth control. Have current charges pending for a violent crime. Does not have a stable living situation and a reliable source of collateral reporting. Has taken an opiate antagonist drug in the last month.

Sites / Locations

  • Medical Univ. of South Carolina

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 1, 2010
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000456
Brief Title
Behavioral Therapy Plus Naltrexone for Alcoholism
Official Title
Comparison of Cognitive Behavioral Therapy and Motivational Enhancement Therapy Plus Naltrexone for Alcoholism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
September 1992 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
August 2002 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. All study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Alcohol Dependence
Keywords
Alcoholism, Alcohol Dependence, Naltrexone, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
naltrexone (Revia)
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavior therapy
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
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets criteria for alcohol dependence, has not had more than one previous inpatient medical detoxification. Consumes on average five standard drinks per day. Able to maintain sobriety for five days (with or without the aid of detoxification medications) as determined by self-report, collateral report, and breathalyzer measurements. Able to read and understand questionnaires and informed consent. Lives within 50 miles of the study site. Exclusion Criteria: Currently meets criteria for any other psychoactive substance dependency disorder. Ever abused opiates. Used psychoactive substance abuse, except marijuana, within the last 30 days as evidenced by patient report, collateral report, and urine drug screen. Meets criteria for disorders of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder. Meets criteria for dissociate disorder or eating disorders. Has current suicidal or homicidal ideation. Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications. Current use of disulfiram (Antabuse). Clinically significant medical problems that would impair participation or limit medication ingestion. Hepatocellular disease. Sexually active females of child bearing potential who are pregnant, nursing, or who are not using a reliable form of birth control. Have current charges pending for a violent crime. Does not have a stable living situation and a reliable source of collateral reporting. Has taken an opiate antagonist drug in the last month.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray Anton, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Univ. of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16012278
Citation
Anton RF, Moak DH, Latham P, Waid LR, Myrick H, Voronin K, Thevos A, Wang W, Woolson R. Naltrexone combined with either cognitive behavioral or motivational enhancement therapy for alcohol dependence. J Clin Psychopharmacol. 2005 Aug;25(4):349-57. doi: 10.1097/01.jcp.0000172071.81258.04.
Results Reference
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Behavioral Therapy Plus Naltrexone for Alcoholism

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