Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381043
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2006-09-26
Brief Title:
Study of Campral Acamprosate for Alcohol Dependence in a Family Medicine Clinic
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Campral Acamprosate Treatment of Alcohol Dependence in a Family Medicine Setting A Randomized Double-Blind Placebo-Controlled Study
Status:
COMPLETED
Status Verified Date:
2017-04
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:
This is a study of a medication acamprosate which is an FDA approved medication for alcohol problems We will be examining whether acamprosate compared to a sugar pill placebo is more effective for helping with drinking in a Family Medicine clinic
Detailed Description:
Acamprosate has been shown to reduce drinking days in alcohol dependent patients and promote abstinence with few reported side effects A limitation of these studies however has been their lack of generalizability due to restrictive inclusion and exclusion criteria Furthermore most of the previous studies of acamprosate have been conducted in Europe in a different treatment setting from the typical American Family Medicine center where alcohol dependent patients are most likely to be first identified in the US
The present study is designed to determine the efficacy of acamprosatefor alcohol dependence in a Family Medicine setting using minimal psychotherapeutic interventions-as would also likely occur in a primary care setting The study will be a 12-week double-blind placebo-controlled randomized trial comparing 666 mg acamprosate tid to placebo in patients at the UNC Family Medicine Center with alcohol dependence Subjects will be seen by Family Medicine physicians and receive brief motivational interventions Primary efficacy will be determined by measuring days abstinent and secondary outcomes include rates of complete abstinence heavy drinking days CGI and GGT in the acamprosate group compared to the placebo group
The present study is designed to determine the efficacy of acamprosatefor alcohol dependence in a Family Medicine setting using minimal psychotherapeutic interventions-as would also likely occur in a primary care setting The study will be a 12-week double-blind placebo-controlled randomized trial comparing 666 mg acamprosate tid to placebo in patients at the UNC Family Medicine Center with alcohol dependence Subjects will be seen by Family Medicine physicians and receive brief motivational interventions Primary efficacy will be determined by measuring days abstinent and secondary outcomes include rates of complete abstinence heavy drinking days CGI and GGT in the acamprosate group compared to the placebo group
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