Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368550
Status:
COMPLETED
Last Update Posted:
2011-06-21
First Post:
2006-08-22
Brief Title:
Sertraline Pharmacotherapy for Alcoholism Subtypes
Sponsor:
UConn Health
Organization:
UConn Health
Study Overview
Official Title:
Sertraline Pharmacotherapy for Alcoholism Subtypes
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgday 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-onsetlate-onset and other relevant pretreatment measures with an approximately equal number of subjects assigned to treatment with sertraline to a maximum of 200 mgday 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
The study employs a parallel-group prospective design in which randomization is balanced on patient subtype early-onsetlate-onset and other relevant pretreatment measures with an approximately equal number of subjects assigned to treatment with sertraline to a maximum of 200 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA013631 | NIH | None | httpsreporternihgovquickSearchR01AA013631 |