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Sponsored by: |
University of Pennsylvania |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00004554 |
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 14 weeks. The followup phase includes two visits at 6 and 9 months after treatment.
Condition | Intervention | Phase |
---|---|---|
Alcoholism Depression |
Drug: naltrexone (Revia) Drug: sertraline (Zoloft) Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Sertraline for Alcohol Dependence and Depression |
Enrollment: | 171 |
Study Start Date: | January 2000 |
Study Completion Date: | February 2006 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Sertraline: Experimental
sertraline
|
Drug: sertraline (Zoloft)
200mg/day
|
Naltrexone: Experimental
naltrexone
|
Drug: naltrexone (Revia)
100mg/day
|
Nal/Sert: Experimental
naltrexone/sertraline
|
Drug: naltrexone (Revia)
100mg/day
Drug: sertraline (Zoloft)
200mg/day
|
Placebo: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo
|
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.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Treatment Research Center, University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Helen Pettinati, PhD | University of Pennsylvania |
Responsible Party: | Treatment Research Center ( Helen Pettinati, PhD ) |
Study ID Numbers: | NIAAAPET09544 |
Study First Received: | February 4, 2000 |
Last Updated: | August 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00004554 History of Changes |
Health Authority: | United States: Federal Government |
Neurotransmitter Agents Depression Psychotropic Drugs Disorders of Environmental Origin Depressive Disorder Serotonin Uptake Inhibitors Serotonin Behavioral Symptoms Mental Disorders |
Alcoholism Naltrexone Substance-Related Disorders Mood Disorders Sertraline Alcohol-Related Disorders Antidepressive Agents Ethanol |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Depression Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Depressive Disorder Serotonin Uptake Inhibitors Pharmacologic Actions Behavioral Symptoms |
Serotonin Agents Mental Disorders Therapeutic Uses Alcoholism Substance-Related Disorders Mood Disorders Sertraline Alcohol-Related Disorders Central Nervous System Agents Antidepressive Agents |