Sertraline Pharmacotherapy for Alcoholism Subtypes - Full Text View

Sponsors and Collaborators:	University of Connecticut National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	University of Connecticut
ClinicalTrials.gov Identifier:	NCT00368550

Purpose

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.

Condition	Intervention	Phase
Alcoholism Alcohol Drinking Alcohol Dependence	Drug: sertraline Drug: Placebo	Phase IV

MedlinePlus related topics: Alcohol Consumption Alcoholism

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Sertraline Pharmacotherapy for Alcoholism Subtypes

Further study details as provided by University of Connecticut:

Primary Outcome Measures:

Number of days on which subjects drink [ Time Frame: 14-week treatment period, 6 months follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Likelihood of total abstinence during the treatment period [ Time Frame: 14-week treatment period, 6 months follow up ] [ Designated as safety issue: No ]
Mean daily alcohol consumption [ Time Frame: 14-week treatment period, 6 months follow up ] [ Designated as safety issue: No ]
Number of days of heavy drinking (defined as >= 4 drinks for females and >= 5 drinks for males) [ Time Frame: 14-week treatment period; 6 months follow up ] [ Designated as safety issue: No ]
Carbohydrate-deficient transferrin levels [ Time Frame: 14-week treatment period; 6 months follow up ] [ Designated as safety issue: No ]
Level of alcohol-related problems [ Time Frame: 14-week treatment period; 6 months follow up ] [ Designated as safety issue: No ]
Frequency of serious adverse events [ Time Frame: 14-week treatment period; 6 months follow up ] [ Designated as safety issue: Yes ]
Frequency of moderate or severe adverse events [ Time Frame: 14-week treatment period; 6 months follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	February 2004
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental sertraline	Drug: sertraline sertraline (to a maximum of 200 mg/day) for 14-week treatment period
2: Placebo Comparator Placebo	Drug: Placebo placebo for 14-week treatment period

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 SSRI's 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 stratified, parallel groups, prospective design in which patient subtype (early-onset/late-onset) is used to assign subjects randomly to medication group in a placebo-controlled trial of sertraline. The study will include a 14-week treatment period, during which 160 early-onset or late-onset alcoholics will receive either sertraline (to a maximum of 200 mg/day) or matching placebo. 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368550

Contacts

Contact: Kristen A. Tremblay, MPH

860-679-4755

tremblay@psychiatry.uchc.edu

Locations

United States, Connecticut
University of Connecticut Health Center	Recruiting
Farmington, Connecticut, United States, 06030
Contact: Kristen A. Tremblay, MPH 860-679-4755 tremblay@psychiatry.uchc.edu
Principal Investigator: Henry R. Kranzler, MD
Sub-Investigator: Howard Tennen, Ph.D.
Sub-Investigator: Jonathan Covault, M.D., Ph.D.
Sub-Investigator: Cheryl Oncken, M.D., M.P.H.
Sub-Investigator: Albert Arias, M.D.
Sub-Investigator: Stephen Armeli, Ph.D.
Sub-Investigator: Carolyn Drazinic, M.D., Ph.D.

Sponsors and Collaborators

University of Connecticut

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Henry R. Kranzler, MD

University of Connecticut Health Center

More Information

University of Connecticut Health Center, Dept. of Psychiatry Research Studies This link exits the ClinicalTrials.gov site

Responsible Party:	University of Connecticut Health Center ( Henry R. Kranzler, M.D. )
Study ID Numbers:	03-225-2, NIAAAKRA013631-04
Study First Received:	August 22, 2006
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00368550
Health Authority:	United States: Federal Government

Keywords provided by University of Connecticut:

Sertraline Pharmacotherapy
Alcoholism Subtypes
Early- vs. Late-Onset Alcoholism

Study placed in the following topic categories:

Mental Disorders
Alcoholism
Substance-Related Disorders
Drinking Behavior
Sertraline

Disorders of Environmental Origin
Alcohol-Related Disorders
Alcohol Drinking
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009