Completed

Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives

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What is being tested

naltrexone

+ sertraline

+ naltrexone

Drug
Who is being recruted

Mental Disorders+2

+ Substance-Related Disorders

+ Alcohol-Related Disorders

From 18 to 65 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2003
See protocol details

Summary

Principal SponsorYale University
Last updated: January 29, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2003

Actual date on which the first participant was enrolled.

This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.

NCT00000451
Principal SponsorYale University
Last updated: January 29, 2013
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

198 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 18 to 65 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

4 inclusion criteria required to participate
Alaska Native having biological Alaska Native ancestry
Meets criteria for alcohol dependence
Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment
Stable residence to ensure that subjects can be located during the study
11 exclusion criteria prevent from participating
Current use of Type 1C antiarrhythmics propafenone and flecainide
Current use of disulfiram
Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine
Females who are pregnant, nursing, or not using a reliable method of birth control
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Naltrexone plus Sertraline

Group II

Experimental
Naltrexone alone

Study Objectives

Primary Objectives

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

New Haven, United StatesOpen in Google Maps
CompletedOne Study Center