Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329407
Status:
COMPLETED
Last Update Posted:
2010-09-08
First Post:
2006-05-22
Brief Title:
The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-08
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 investigation will assess the effectiveness of topiramate in reducing ethanol consumption by alcohol dependent subjects It also will seek to establish whether topiramate can be safely used in this population including whether it might be subject to abuse by alcohol dependent individuals
A secondary goal of this study is to assess the effects of topiramate on verbal fluency during treatment for alcohol dependence
A secondary goal of this study is to assess the effects of topiramate on verbal fluency during treatment for alcohol dependence
Detailed Description:
Alcoholism is a disorder that produces extensive morbidity and mortality Substantial progress has been made in the development of medications that can help to promote abstinence in alcohol dependent individuals However investigations of the most promising drugs particularly naltrexone and acamprosate suggest that these agents have at best moderate efficacy and there is a great need for additional medications for the treatment of alcoholism
The results of a recent study suggest that the administration of the anticonvulsant agent topiramate helps alcoholic individuals to maintain abstinence Johnson et al 2003 The objectives of this study is to determine whether topiramate will reduce the consumption of alcohol in subjects dependent on this substance as has been previously reportedOther study objectives are to assess the abuse liability properties of topiramate in alcohol dependent subjects and to examine the effects of chronic topiramate administration on cognitive functioning
This will be a thirteen week long open label clinical trial of the effects of topiramate administration on ethanol consumption by alcohol dependent subjects
Subjects will be asked to provide informed consent and then will be screened on the same day to determine if they meet study eligibility criteria Subjects will be asked to return to provide two urines over the following week
Baseline measures of mood craving withdrawal cognitive functioning and physical health will be obtained In the afternoon they will receive their first dose of medication Their responses to this medication challenge will be assessed over a 3-hour period
During the drug treatment phase subjects will be asked to come to the clinic weekly for assessment and manual guided therapy during weeks 1-4 and biweekly during weeks 6-8 On day 85 subjects will be seen at the clinic for a termination visit
The results of a recent study suggest that the administration of the anticonvulsant agent topiramate helps alcoholic individuals to maintain abstinence Johnson et al 2003 The objectives of this study is to determine whether topiramate will reduce the consumption of alcohol in subjects dependent on this substance as has been previously reportedOther study objectives are to assess the abuse liability properties of topiramate in alcohol dependent subjects and to examine the effects of chronic topiramate administration on cognitive functioning
This will be a thirteen week long open label clinical trial of the effects of topiramate administration on ethanol consumption by alcohol dependent subjects
Subjects will be asked to provide informed consent and then will be screened on the same day to determine if they meet study eligibility criteria Subjects will be asked to return to provide two urines over the following week
Baseline measures of mood craving withdrawal cognitive functioning and physical health will be obtained In the afternoon they will receive their first dose of medication Their responses to this medication challenge will be assessed over a 3-hour period
During the drug treatment phase subjects will be asked to come to the clinic weekly for assessment and manual guided therapy during weeks 1-4 and biweekly during weeks 6-8 On day 85 subjects will be seen at the clinic for a termination visit
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