Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210925
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-13
Brief Title:
An Efficacy and Safety Study of Topiramate in the Treatment of Alcohol Dependence
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Flexible Dose Study to Assess the Safety and Efficacy of Topiramate in the Treatment of Alcohol Dependence
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of topiramate compared to placebo in patients with alcohol dependence
Detailed Description:
The impact of alcoholism can be reduced through effective treatments which may include medical psychological and social interventions The main goals of alcohol-dependence treatment are to assist patients in avoiding alcohol developing better strategies for managing stress and improving self-esteem and quality of life Studies have demonstrated that treatments for alcohol use disorders can be effective but their effectiveness is often limited Although the optimal goal of treatment should be total abstinence even patients who are unable to achieve this goal may still benefit from treatments leading to a reduction in drinking Medications are commonly used in other addictive disorders such as nicotine and opioid dependence suggesting that this intervention could be useful in the treatment of alcohol dependence This is a randomized double-blind flexible dose study to determine if topiramate a prescription medication approved by the Food Drug Administration for the treatment of epilepsy and the prevention of migraine administered at a dose of 300mg per day or the subjects maximum tolerated dose is safe and effective compared with placebo in patients with alcohol dependence The study hypothesis is that topiramate will be more effective than placebo in reducing the percentage of heavy drinking days 5 or more standard drinks per day for men and 4 or more standard drinks per day for women in patients with alcohol dependence The patients will receive topiramate tablets 25mg andor 100mg or matching placebo Study medication is taken in increasing doses starting at 25 mgday up to 300 mg per day or maximum tolerated dose during the first 6 weeks and the achieved dose is maintained for an additional 8 weeks
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