NCT00141115

Levetiracetam for the Treatment of Alcohol Dependence and Anxiety

Pilot Trial of Levetiracetam in the Treatment of Alcohol Dependence With Comorbid Anxiety

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholism
• Generalized Anxiety Disorder
• Panic Disorder
• Social Phobia
• Anxiety Disorders

Interventions

Type	Name	Description
DRUG	levetiracetam	Levetiracetam 1500 mg BID

Timeline

• Start date: 2004-03-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-09-01
• Last updated: 2019-04-24
• Results posted: 2017-09-15

Locations

1 site across 1 country: United States