Sertraline Pharmacotherapy for Alcoholism Subtypes

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00368550
First received: August 22, 2006
Last updated: June 17, 2011
Last verified: June 2011
  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. This involved administering sertraline (to a maximum of 200 mg/day) or an inactive placebo for a 14-week treatment period.


Condition Intervention Phase
Alcoholism
Drug: Sertraline
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Sertraline Pharmacotherapy for Alcoholism Subtypes

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Number of Days on Which Subjects Drank [ Time Frame: 12-week treatment period ] [ Designated as safety issue: No ]
    Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as drinking days.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as heavy drinking days.

  • Change in the Level of Alcohol-related Problems [ Time Frame: 12-week treatment period compared with baseline value ] [ Designated as safety issue: No ]
    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.


Enrollment: 134
Study Start Date: February 2004
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Henry R. Kranzler, MD University of Pennsylvania
  More Information

No publications provided by University of Connecticut Health Center

Additional 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
Study First Received: August 22, 2006
Results First Received: June 4, 2010
Last Updated: June 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Alcohol Drinking
Alcohol Dependence
Sertraline Pharmacotherapy
Alcoholism Subtypes
Early- versus Late-Onset Alcoholism

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014