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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
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
UConn Health

Tracking Information
First Submitted Date  ICMJE August 22, 2006
First Posted Date  ICMJE August 24, 2006
Results First Submitted Date  ICMJE June 4, 2010
Results First Posted Date  ICMJE August 31, 2010
Last Update Posted Date June 21, 2011
Study Start Date  ICMJE February 2004
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2006)
Number of days on which subjects drink
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2006)
  • Likelihood of total abstinence during the treatment period
  • Mean daily alcohol consumption
  • Percent days heavy drinking (defined as > 4 drinks for females and > 5 drinks for males)
  • Carbohydrate-deficient transferrin levels
  • Level of alcohol-related problems
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sertraline Pharmacotherapy for Alcoholism Subtypes
Official Title  ICMJE Sertraline Pharmacotherapy for Alcoholism Subtypes
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alcoholism
Intervention  ICMJE
  • Drug: Sertraline
    Sertraline (to a maximum of 200 mg/day) for 14-week treatment period
    Other Name: Zoloft
  • Drug: Placebo
    Placebo for 14-week treatment period
Study Arms  ICMJE
  • Experimental: 1
    Oral sertraline, cognitive-behavioral counseling to maintain abstinence from alcohol
    Intervention: Drug: Sertraline
  • Placebo Comparator: 2
    Placebo, cognitive-behavioral counseling to maintain abstinence from alcohol
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2009)
134
Original Enrollment  ICMJE
 (submitted: August 22, 2006)
160
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00368550
Other Study ID Numbers  ICMJE 03-225-2
R01AA013631 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Henry R. Kranzler, M.D., University of Pennsylvania
Study Sponsor  ICMJE UConn Health
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Henry R. Kranzler, MD University of Pennsylvania
PRS Account UConn Health
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP