Sertraline Pharmacotherapy for Alcoholism Subtypes
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.
|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|
- 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.
- 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.
|Study Start Date:||February 2004|
|Study Completion Date:||December 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Oral sertraline, cognitive-behavioral counseling to maintain abstinence from alcohol
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
Placebo for 14-week treatment period
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.
|United States, Connecticut|
|University of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030|
|Principal Investigator:||Henry R. Kranzler, MD||University of Pennsylvania|