Sertraline for Alcohol Dependence and Depression
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00004554 |
Recruitment Status :
Completed
First Posted : February 7, 2000
Last Update Posted : October 6, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcoholism Depression | Drug: naltrexone (Revia) Drug: sertraline (Zoloft) Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 171 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Sertraline for Alcohol Dependence and Depression |
Study Start Date : | January 2000 |
Actual Primary Completion Date : | August 2005 |
Actual Study Completion Date : | February 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Sertraline
sertraline
|
Drug: sertraline (Zoloft)
200mg/day |
Experimental: Naltrexone
naltrexone
|
Drug: naltrexone (Revia)
100mg/day |
Experimental: Nal/Sert
naltrexone/sertraline
|
Drug: naltrexone (Revia)
100mg/day Drug: sertraline (Zoloft) 200mg/day |
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo |
- Subjects self-report of alcohol use, measured by the Timeline Followback (TLFB), and depressive symptoms measured by scores on the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HRSD). [ Time Frame: 14 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female outpatients 18 75 years of age.
- Patients must have met DSM-IV criteria for (primary or substance-induced) major depressive episode prior to randomization.
- 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.
- Patients must have drank sufficient alcohol in the month prior to coming for treatment so that a practical assessment in reductions in drinking during and after treatment can be performed. The guidelines we will follow for this study as to what we think is sufficient will be that the patient in the month prior to coming to treatment will have drank on 40% or more of the days or drank more than 40 standard drinks (an average of 10 drinks per week).
- Patients must have successfully completed medical detoxification for alcohol (are abstinent for 4 consecutive days) or if medical detoxification is not indicated, have been abstinent for 4 consecutive days since coming to treatment but before initiating the study medication/placebo.
- 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.
Exclusion Criteria:
- Patients with evidence of opiate use in the past 30 days as assessed by self-report and intake urine drug screens (only one repeat testing permitted). Patients with a history of treatment for opiate dependence will be excluded.
- Patients who, within the past year, met DSM IV criteria for dependence on any psychoactive substance other than alcohol or nicotine. Patients who test positive on the urine drug screen (with the exception of THC) at the initial visit (only one repeat testing permitted).
- Patients who meet DSM-IV criteria for past history or current disorder of schizophrenia or any psychotic disorder, or bipolar disorder.
- Patients with evidence or history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease. (If there is a history of such disease but the condition has been stable for more than one year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.)
- Patients with abnormal liver function tests (AST or ALT) (more than 3.5 times the upper level of the normal value) or patients with any abnormal elevation in bilirubin.
- 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 have taken fluoxetine (Prozac) during the 6 weeks prior to randomization --due to its long half-life.
- Patients who have taken monoamine oxidase inhibitors (MAOI) during the 2 weeks prior to randomization -- due to the potential toxicity of combining MAOI medications with serotonin-specific ones. (Patients will also be instructed not to take MAOI for 2 weeks after completing the study.)
- 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 who are unable to read or print in English.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004554
United States, Pennsylvania | |
Treatment Research Center, University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Helen Pettinati, PhD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00004554 |
Other Study ID Numbers: |
NIAAAPET09544 |
First Posted: | February 7, 2000 Key Record Dates |
Last Update Posted: | October 6, 2015 |
Last Verified: | September 2013 |
Alcoholism Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Naltrexone Sertraline Alcohol Deterrents |
Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |