To determine if levetiracetam is effective in treating alcohol dependence in patients with anxiety symptoms. We 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.

Condition	Intervention	Phase
Alcoholism Generalized Anxiety Disorder Panic Disorder Social Phobia Substance-induced anxiety disorder	Drug: levetiracetam	Phase II

Further Study Details: 

Primary Outcomes: Percent drinking days; Hamilton Anxiety Score
Secondary Outcomes: Drinks per drinking days; Percent heavy drinking days; CGI
Expected Total Enrollment:  30

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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Men and women between the ages of 18-65 who meet 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, 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-TR supported by the 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 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 (SBP > 150 mm Hg, DBP > 90 mm Hg, or a sitting quietly 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00141115

John J Mariani, MD      212-543-5987    jm2330@columbia.edu

New York
      New York State Psychiatric Institute, New York,  New York,  10032,  United States; Recruiting

Study chairs or principal investigators

Frances R Levin, MD,  Principal Investigator,  New York State Psychiatric Institute   

Study ID Numbers:  4773
Last Updated:  August 31, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00141115
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06