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Sertraline Pharmacotherapy for Alcoholism Subtypes

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: NCT00368550
Recruitment Status : Completed
First Posted : August 24, 2006
Results First Posted : August 31, 2010
Last Update Posted : June 21, 2011
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine whether Sertraline, compared to placebo, is effective in the treatment of alcohol dependence as a function of the subtype of alcoholic patient being treated. This involved administering sertraline (to a maximum of 200 mg/day) or an inactive placebo for a 14-week treatment period.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Sertraline Drug: Placebo Phase 4

Detailed Description:

In an effort to broaden the options for pharmacotherapy of alcoholism, this study will examine the effects of sertraline, a selective serotonin reuptake inhibitor (SSRI), for the treatment of alcohol dependence. The study is based on evidence that, although SSRI therapy is not appropriate for all alcoholics, there exists a substantial subgroup of alcoholics for whom SSRIs appear to exert a clinically important effect. Sertraline is among the most widely prescribed psychotropic medications in the world. Consequently, this study will examine the safety and efficacy of sertraline, the mechanism and duration of those effects and the best method for subtyping alcoholics to identify individuals for whom the medication is most likely to produce a clinically important reduction in drinking behavior.

The study employs a parallel-group, prospective design in which randomization is balanced on patient subtype (early-onset/late-onset) and other relevant pretreatment measures with an approximately equal number of subjects assigned to treatment with sertraline (to a maximum of 200 mg/day) or placebo. The study will include a 14-week treatment period; because the 2 weeks are for medication taper, efficacy will be evaluated over the first 12 treatment weeks. A total of 160 early-onset or late-onset alcoholics will be randomized. Daily process measures of positive and negative events, global perceived stress, mood, desire to drink, and drinking frequency and intensity, collected using interactive voice response technology, will provide insight into the mechanisms by which sertraline may exert its effects. Coping-skills training will be provided weekly for the first 6 weeks, then every other week for the last 8 weeks of the study. A 6-month post-treatment follow-up period will evaluate the duration of medication effects. This study will also examine the relation between genotypes at a number of relevant loci and both risk of alcohol dependence and response to sertraline treatment.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Sertraline Pharmacotherapy for Alcoholism Subtypes
Study Start Date : February 2004
Primary Completion Date : June 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Oral sertraline, cognitive-behavioral counseling to maintain abstinence from alcohol
Drug: Sertraline
Sertraline (to a maximum of 200 mg/day) for 14-week treatment period
Other Name: Zoloft
Placebo Comparator: 2
Placebo, cognitive-behavioral counseling to maintain abstinence from alcohol
Drug: Placebo
Placebo for 14-week treatment period

Outcome Measures

Primary Outcome Measures :
  1. Number of Days on Which Subjects Drank [ Time Frame: 12-week treatment period ]
    Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as drinking days.

Secondary Outcome Measures :
  1. Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks) [ Time Frame: 12-week treatment period ]
    Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as heavy drinking days.

  2. Change in the Level of Alcohol-related Problems [ Time Frame: 12-week treatment period compared with baseline value ]
    Measured using the SIP (Short Inventory of Problems), which was administered at pretreatment and at the end of treatment. The range of scores on the SIP is 0 (no alcohol-related problems) to 45 (most severe alcohol-related problems) and the time frame for reporting is the preceding 3 months. The data presented here represent a difference score of treatment minus baseline.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Current episode (i.e., in the preceding month) of alcohol dependence defined by Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) criteria
  • 18-65 years of age
  • Abstinent from alcohol for a period of at least 3 days prior to baseline research assessment
  • Able to read English and complete study evaluations
  • Male, or if female, without active reproductive potential
  • Participants will have signed informed consent

Exclusion Criteria:

  • Currently meets criteria for dependence on a psychoactive substance other than alcohol and nicotine
  • Regular use of psychoactive drugs including anxiolytics and antidepressants
  • Current use of disulfiram or naltrexone
  • Current major depression or psychosis (or other severe psychiatric disability e.g., suicidality, current mania)
  • Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac pathology, which in the opinion of the evaluating physician would preclude the patient from study adherence or be of potential harm to the subject
Contacts and Locations

Information from the National Library of Medicine

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): NCT00368550

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Henry R. Kranzler, MD University of Pennsylvania
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Henry R. Kranzler, M.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00368550     History of Changes
Other Study ID Numbers: 03-225-2
R01AA013631 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2006    Key Record Dates
Results First Posted: August 31, 2010
Last Update Posted: June 21, 2011
Last Verified: June 2011

Keywords provided by UConn Health:
Alcohol Drinking
Alcohol Dependence
Sertraline Pharmacotherapy
Alcoholism Subtypes
Early- versus Late-Onset Alcoholism

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents