Levetiracetam for the Treatment of Alcohol Dependence and Anxiety
Condition: Alcoholism; Generalized Anxiety Disorder; Panic Disorder; Social Phobia; Anxiety Disorders
MeSH terms: Alcoholism; Anxiety Disorders; Panic Disorder; Phobia, Social
Intervention: levetiracetam
Intervention description: Levetiracetam 1500 mg BID
Intervention MeSH terms: Levetiracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Substance-induced anxiety disorder

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.
    

Eligibility criteria:

        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.