Completed

Sertraline for Alcohol Dependence and Depression

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What is being tested

sertraline (Zoloft)

+ naltrexone (Revia)

+ naltrexone (Revia)

Drug
Who is being recruted

Behavior+5

+ Mental Disorders

+ Behavioral Symptoms

From 21 to 65 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: January 2000
See protocol details

Summary

Principal SponsorUniversity of Pennsylvania
Last updated: October 6, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2000

Actual date on which the first participant was enrolled.

The proposed study will examine managing relapse in patients with alcohol dependence and depression using a 14-week double-blind, placebo-controlled, combination of 100 mg/day of naltrexone, 200 mg/day of sertraline, and individual, cognitive behavioral therapy (CBT). For testing the medication, the design will be 2x2, consisting of four groups: naltrexone/sertraline, naltrexone only, sertraline only, placebo. All four groups will receive once weekly sessions of CBT given by therapists experienced in working with patients with substance disorders and trained in the principles of CBT.

NCT00004554
Principal SponsorUniversity of Pennsylvania
Last updated: October 6, 2015
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

171 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 21 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

BehaviorMental DisordersBehavioral SymptomsSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced DisordersAlcoholismDepression

Criteria

7 inclusion criteria required to participate
Females of childbearing potential must have a negative pregnancy test and not contemplating pregnancy within the next 6 months. They must also use a contraceptive method judged by the investigator to be effective
Male and female outpatients 18 75 years of age
Patients must have a current DSM-IV diagnosis of alcohol dependence
Patients must have a total score of 10 or higher on the Hamilton Depression Scaleat the day of randomization. Also, item 1 on the scale must be > 1
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11 exclusion criteria prevent from participating
Past use of antidepressants or other psychotropic medications (except as specified above) within 7 days of randomization
Patients on concomitant therapy with an investigational drug, or patients who have been in an investigational drug study within one month prior to entering this study
Patients requiring concomitant therapy with any psychotropic drug (with the exception of benadryl used sparingly if necessary for sleep or oxeazepam for detoxification or nicotine replacement therapy)
Patients who are unable to read or print in English
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

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
sertraline

Group II

Experimental
naltrexone

Group III

Experimental
naltrexone/sertraline

Group IV

Placebo
Placebo

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

Treatment Research Center, University of Pennsylvania

Philadelphia, United StatesOpen Treatment Research Center, University of Pennsylvania in Google Maps
CompletedOne Study Center