Clinical trial NCT00141115 (phase 2, status: completed)
Conditions: alcoholism, generalized anxiety disorder, panic disorder, social phobia, anxiety disorders
ICD codes: Z63.72, F41.1, F40.01, F40.02, F41.0, F41.1, F41.9, F40.9, F43.22, F41.0, F93.0, F12.980
Drugs: levetiracetam
SMILES: CC(C)CC1=CC=C(C=C1)C(C)C(O)=O
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.