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Home > "S" Clinical Trials Conditions > Sertraline for Alcohol Dependence and Depression  Sertraline for Alcohol Dependence and Depression
Sertraline for Alcohol Dependence and Depression
For Condition: Depression,Alcoholism
Status: Completed
Sponsor(s): National Institute on Alcohol Abuse and Alcoholism (NIAAA) ,
Synopsis: This study will examine depressed alcoholic outpatients to assess whether combining naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking and depression over either medication alone or placebo. A secondary aim is to determine whether certain patient features will predict response to sertraline, naltrexone or the combination of the two drugs. Subjects will be randomized into treatment groups for 16 weeks. The followup phase includes two visits at 6 and 9 months after treatment.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 21 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Current diagnosis of major depression for a 2-week duration following discontinuation of drinking or prior to study. - Meets criteria for alcohol dependence. - Drank a minimum of 48 standard alcoholic drinks prior to treatment (average of 12 drinks/week) on 40% of the 30 days before treatment. - Able to maintain abstinence for four days with or without the aid of detoxification medications. - Lives within 50 miles of the study site. - Speaks, understands and prints in English. Exclusion Criteria: - Ever abused or dependent on opiates or evidence of opiate use in month prior to treatment. - Meets criteria for dependence on any substance other than alcohol (except nicotine). - Tests positive on the urine drug screen at the initial visit. - Meets criteria for panic, obsessive-compulsive, post-traumatic stress, or eating disorders. - Meets current or lifetime criteria for bipolar affective disorder, schizophrenia or any psychiatric disorder, or organic mental disorder. - Has evidence of or a history of significant hematological, pulmonary, endocrine, cardiovascular, renal, or gastrointestinal disease. - Hepatocellular disease. - Abnormal elevation in bilirubin. - Needs treatment with any psychoactive medication including antiseizure medications. - Current use of disulfiram. - Has taken a monoamine oxidase inhibitors, serotonin reuptake inhibitor or opiate antagonist in the month prior to randomization. - Is or has been taking an investigational drug within one month prior to study. - Females who are pregnant, contemplating pregnancy in the next six months, nursing or not using an effective contraceptive birth control method (if relevant).
Total Enrollment: 160
Location and Contact Information:
Treatment Research Center, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Additional Information:
Study ID Numbers: NIAAAPET09544;
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004554
Other Depression Studies:
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2. Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal
3. Genetic Factors and Interrelationships for Cancer Risk-Related Behaviors and Complex Traits
4. Trazodone for Sleep Disturbance in Early Alcohol Recovery
5. Sertraline and Naltrexone for Alcohol Dependence
Related Studies:
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Sertraline for Alcohol Dependence and Depression
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