Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00141115
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2005-08-31
Brief Title:
Levetiracetam for the Treatment of Alcohol Dependence and Anxiety
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Pilot Trial of Levetiracetam in the Treatment of Alcohol Dependence With Comorbid Anxiety
Status:
COMPLETED
Status Verified Date:
2019-04
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:
The purpose of this study is to determine if levetiracetam is effective in treating alcohol dependence in patients with anxiety symptoms The researchers hypothesize that individuals are unable to reduce or discontinue alcohol use because of significant anxiety mood and sleep disturbance symptoms that accompany reduction in alcohol use
Detailed Description:
Alcohol dependence is frequently associated with anxiety disorders Treatment studies of individuals suffering from both alcohol dependence and anxiety have been limited Anti-seizure medications have been used for the treatment of alcohol withdrawal for three decades More recently anti-seizure medications have been shown to reduce drinking and promote abstinence and reduce drinking in abstinent alcoholics Levetiracetam is a newer anti-seizure medication with a structure different than that of other anti-seizure medications that is safe and generally well tolerated The Food and Drug Administration FDA has approved levetiracetam for use with other anti-seizure medications in the treatment of epilepsy in adults The metabolism of levetiracetam is less complicated than older anti-seizure medications which makes it easier to use and better tolerated and it is not likely to interact with other medicines Levetiracetam has been shown to prevent anxiety during sedative withdrawal which is similar to alcohol withdrawal in a laboratory study using mice Levetiracetam also had anti-anxiety effects in laboratory study using mice Given that other anti-seizure medications have been shown to be helpful in treating alcohol dependence that levetiracetam is not likely to have interactions with other medications and that in animals levetiracetam appeared to be helpful for treating a condition similar to alcohol dependence and anxiety we believe it should be studied for the treatment of alcohol dependent patients with anxiety disorders
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