Clinical trial NCT00368550: Sertraline Pharmacotherapy for Alcoholism Subtypes
Official title: Sertraline Pharmacotherapy for Alcoholism Subtypes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Keywords: Alcohol Drinking
Alcohol Dependence
Sertraline Pharmacotherapy
Alcoholism Subtypes
Early- versus Late-Onset Alcoholism
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2006-08-24
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Days on Which Subjects Drank
timeFrame: 12-week treatment period
Secondary outcomes:
measure: Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks)
timeFrame: 12-week treatment period
measure: Change in the Level of Alcohol-related Problems
timeFrame: 12-week treatment period compared with baseline value
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: University of Pennsylvania
name: Henry R. Kranzler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kranzler HR, Armeli S, Tennen H, Covault J. 5-HTTLPR genotype and daily negative mood moderate the effects of sertraline on drinking intensity. Addict Biol. 2013 Nov;18(6):1024-31. doi: 10.1111/adb.12007. Epub 2012 Nov 12.
citation: Kranzler HR, Armeli S, Tennen H. Post-treatment outcomes in a double-blind, randomized trial of sertraline for alcohol dependence. Alcohol Clin Exp Res. 2012 Apr;36(4):739-44. doi: 10.1111/j.1530-0277.2011.01659.x. Epub 2011 Oct 7.