Naltrexone Treatment for Alcoholism

Back to results

Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

naltrexone (Revia)

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets criteria for alcohol dependence. Committed to alcohol abstinence as a treatment goal. Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status. Exclusion Criteria: Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine). Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy. Females who are pregnant, lactating, or not using a reliable method of contraception. Currently experiencing a serious medical condition that would place them at risk or interfere with study participation. Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal. Have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone. Vocabulary below the 5th grade reading level. Abnormal MRI scan. HIV infection due to the neurological sequelae. Significant central nervous system diseases. Seizure disorder or history of closed head trauma. Neuroendocrine disorders. Treatment with opiates within the last six months.

Sites / Locations

Johns Hopkins Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00000438

First Posted

November 2, 1999

Last Updated

May 13, 2010

Sponsor

Johns Hopkins University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT00000438

Brief Title

Naltrexone Treatment for Alcoholism

Official Title

Naltrexone Treatment for Alcoholism: Predicting Outcome

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Johns Hopkins University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. This part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of the study.

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

Allocation

Randomized

Enrollment

192 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

naltrexone (Revia)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Meets criteria for alcohol dependence. Committed to alcohol abstinence as a treatment goal. Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status. Exclusion Criteria: Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine). Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy. Females who are pregnant, lactating, or not using a reliable method of contraception. Currently experiencing a serious medical condition that would place them at risk or interfere with study participation. Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal. Have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone. Vocabulary below the 5th grade reading level. Abnormal MRI scan. HIV infection due to the neurological sequelae. Significant central nervous system diseases. Seizure disorder or history of closed head trauma. Neuroendocrine disorders. Treatment with opiates within the last six months.

Facility Information:

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Alcoholism

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial