Completed

Naltrexone Treatment for Alcoholism: Predicting Outcome

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What is being tested

naltrexone (Revia)

Drug
Who is being recruted

Mental Disorders+2

+ Substance-Related Disorders

+ Alcohol-Related Disorders

From 30 to 55 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
See protocol details

Summary

Principal SponsorJohns Hopkins University
Last updated: May 14, 2010
Sourced from a government-validated database.Claim as a partner

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.

NCT00000438
Principal SponsorJohns Hopkins University
Last updated: May 14, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

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

192 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced DisordersAlcoholism

Criteria

3 inclusion criteria required to participate
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.
Meets criteria for alcohol dependence.
13 exclusion criteria prevent from participating
HIV infection due to the neurological sequelae.
Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal.
Females who are pregnant, lactating, or not using a reliable method of contraception.
Seizure disorder or history of closed head trauma.
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Johns Hopkins Hospital

Baltimore, United StatesOpen Johns Hopkins Hospital in Google Maps
CompletedOne Study Center