Sertraline Pharmacotherapy for Alcoholism Subtypes

Condition(s) targeted: Alcoholism

Intervention: Sertraline (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Connecticut

Official(s) and/or principal investigator(s):
Henry R. Kranzler, MD, Principal Investigator, Affiliation: University of Connecticut Health Center

Overall contact:
Kristen A. Tremblay, MPH, Phone: 860-679-4755, Email: tremblay@psychiatry.uchc.edu

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.

Official title: Sertraline Pharmacotherapy for Alcoholism Subtypes

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Number of days on which subjects drink

Secondary outcome:

Likelihood of total abstinence during the treatment period

Mean daily alcohol consumption

Number of days of heavy drinking (defined as >= 4 drinks for females and >= 5 drinks for males)

Carbohydrate-deficient transferrin levels

Level of alcohol-related problems

Frequency of serious adverse events

Frequency of moderate or severe adverse events

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 stratified, parallel-group, prospective design in which patient subtype (early-onset/late-onset) is used to assign subjects randomly to a 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Kristen A. Tremblay, MPH, Phone: 860-679-4755, Email: tremblay@psychiatry.uchc.edu

University of Connecticut Health Center, Farmington, Connecticut 06030, United States; Recruiting
Kristen A. Tremblay, MPH, Phone: 860-679-4755, Email: tremblay@psychiatry.uchc.edu
Henry R. Kranzler, MD, Principal 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., Sub-Investigator

University of Connecticut Health Center, Dept. of Psychiatry Research Studies

Starting date: February 2004
Ending date: December 2009
Last updated: February 7, 2009