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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental | Levetiracetam 1500 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levetiracetam | Drug | Levetiracetam 1500 mg BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants Who Reported Reductions in Alcohol Consumption | Number of participants who reduced drinking during the trial | over 9 weeks of study or length of participation |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Drinking Days | daily drinking assessed each of study participation, reported percent of drinking days for 28 days prior to study initiation compared to last 28 days of study participation-as reported on the Time line follow back | assessed daily, reported for baseline 28 days compared to last 28 days of study participation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frances R Levin, MD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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| Label | URL |
|---|---|
| STARS clinic website | View source |
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Participants were enrolled under open-label conditions.
Three participants were enrolled into this clinical trial at the New York State Psychiatric Insitute/Columbia University Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam | Levetiracetam 1500 mg BID |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam | Levetiracetam 1500 mg BID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants Who Reported Reductions in Alcohol Consumption | Number of participants who reduced drinking during the trial | Number of participants who were drinking less at the end of the study compared to the beginning. | Posted | Count of Participants | Participants | over 9 weeks of study or length of participation |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levetiracetam 1500 mg Twice Daily | Levitiracetam 1500 mg administered twice daily under open label conditions. |
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poor recruitment leading to small number of participants in the analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John J. Mariani | New York State Psychiatric Institute | 2125435987 | jm2330@columbia.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000098647 | Generalized Anxiety Disorder |
| D016584 | Panic Disorder |
| D000072861 | Phobia, Social |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Percent of Drinking Days | daily drinking assessed each of study participation, reported percent of drinking days for 28 days prior to study initiation compared to last 28 days of study participation-as reported on the Time line follow back | Posted | Mean | Standard Deviation | percentage of days | assessed daily, reported for baseline 28 days compared to last 28 days of study participation |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
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| D010698 | Phobic Disorders |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |