Alcoholism, Anxiety Disorders, Generalized Anxiety Disorder, Panic Disorder, Social Phobia
Conditions
Keywords
Substance-induced anxiety disorder
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.
Interventions
DRUGlevetiracetam
Levetiracetam 1500 mg BID
Sponsors
UCB Pharma
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and women between the ages of 18-65 who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence and a comorbid anxiety disorder, including: panic disorder, social phobia, generalized anxiety disorder, substance-induced anxiety disorder and anxiety disorder, no otherwise specified (NOS). * Individuals capable of giving informed consent and capable of complying with study procedures. * Individuals must have clinically significant anxiety. * Individuals must have current average alcohol use over past 28 days with \> 4 drinking days per week and \>4 standard drinks/drinking day for women and \> 5 standard drinks/drinking day for men. * Women of child-bearing age will be included provided that they are not pregnant, based on the results of a blood pregnancy test done at the time of screening and agree to use a method of contraception with proven efficacy and not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study. If a woman becomes pregnant the study medication will be discontinued. * Individual's breathalyzer reading at the time of signing consent must be \< 0.04%.
Exclusion criteria
* Subjects with any current Axis I psychiatric disorder as defined by DSM-IV-Text Revision (DSM-IV-TR) supported by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition (SCID-I/P) that in the investigator's judgment might require pharmacological intervention, with the exceptions of alcohol dependence and a comorbid anxiety disorder (panic disorder, social phobia, generalized anxiety disorder, substance-induced anxiety disorder and anxiety disorder, NOS). Current diagnoses of post-traumatic stress disorder (PTSD) or obsessive-compulsive disorder are exclusionary. * Individuals with evidence of moderate to severe alcohol withdrawal that would require pharmacologic intervention. * Individuals meeting DSM IV criteria for current cocaine or opioid dependence. * Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension and tachycardia (systolic blood pressure \[SBP\] \> 150 mm Hg, diastolic blood pressure \[DBP\] \> 90 mm Hg, or a sitting quietly heart rate \[HR\] \> 100 bpm), acute hepatitis (patients with chronic mildly elevated transaminase levels ((2-3 x upper limit of normal) are acceptable) or poorly controlled diabetes. * Patients currently taking prescribed psychotropic medications. * Patients with a known sensitivity to levetiracetam. * Individuals who have exhibited suicidal or homicidal behavior within the past two years or have current active suicidal ideation. * Women who are pregnant or nursing. * Individuals physiologically dependent on any other drugs (excluding nicotine, caffeine). * Individuals with a history of a hazardous drinking behavior (e.g., driving while intoxicated convictions, violent crimes committed while intoxicated) will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Reported Reductions in Alcohol Consumption | over 9 weeks of study or length of participation | Number of participants who reduced drinking during the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Drinking Days | assessed daily, reported for baseline 28 days compared to last 28 days of study participation | 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 |
Countries
United States
Participant flow
Recruitment details
Three participants were enrolled into this clinical trial at the New York State Psychiatric Insitute/Columbia University Medical Center.
Pre-assignment details
Participants were enrolled under open-label conditions.
Participants by arm
| Arm | Count |
|---|---|
| Levetiracetam Levetiracetam 1500 mg BID | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Levetiracetam |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Participants Who Reported Reductions in Alcohol Consumption
Number of participants who reduced drinking during the trial
Time frame: over 9 weeks of study or length of participation
Population: Number of participants who were drinking less at the end of the study compared to the beginning.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Levetiracetam 1500 mg Twice Daily | Participants Who Reported Reductions in Alcohol Consumption | 3 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
Time frame: assessed daily, reported for baseline 28 days compared to last 28 days of study participation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levetiracetam 1500 mg Twice Daily | Percent of Drinking Days | Baseline percent of drinking days | 67.9 percentage of days | Standard Deviation 10.7 |
| Levetiracetam 1500 mg Twice Daily | Percent of Drinking Days | Last 28 days percent of drinking days | 27.6 percentage of days | Standard Deviation 10.1 |