Sertraline Pharmacotherapy for Alcoholism Subtypes

Alcoholism Clinical Trial

Official title:

Sertraline Pharmacotherapy for Alcoholism Subtypes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368550
• Other study ID #: 03-225-2
• Secondary ID: R01AA013631
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2006
• Last updated: June 17, 2011
• Start date: February 2004
• Est. completion date: December 2009

Study information

• Verified date: June 2011
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Sertraline
Sertraline (to a maximum of 200 mg/day) for 14-week treatment period
• Placebo
Placebo for 14-week treatment period

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut Health Center	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Days on Which Subjects Drank	Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as drinking days.	12-week treatment period	No
Secondary	Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks)	Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as heavy drinking days.	12-week treatment period	No
Secondary	Change in the Level of Alcohol-related Problems	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.	12-week treatment period compared with baseline value	No