Completed

Naltrexone Treatment for Alcoholism

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

naltrexone (Revia)

Drug
Who is being recruted

Alcoholism

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.

Official TitleNaltrexone Treatment for Alcoholism: Predicting Outcome 
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 30 to 55 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alcoholism
Criteria
3 inclusion criteria required to participate
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
13 exclusion criteria prevent from participating
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

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
Suspended
Johns Hopkins HospitalBaltimore, United StatesSee the location
CompletedOne Study Center