Levetiracetam for the Treatment of Alcohol Dependence and Anxiety

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00141115
First received: August 31, 2005
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Alcoholism
Generalized Anxiety Disorder
Panic Disorder
Social Phobia
Anxiety Disorders
Drug: levetiracetam
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Trial of Levetiracetam in the Treatment of Alcohol Dependence With Comorbid Anxiety

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Percent drinking days [ Time Frame: over 9 weeks of study or length of participation ] [ Designated as safety issue: No ]
  • Hamilton Anxiety Score [ Time Frame: week 8 score or last week of study participation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drinks per drinking days [ Time Frame: during last 4 weeks of study participation ] [ Designated as safety issue: No ]
  • Percent heavy drinking days [ Time Frame: over last 4 weeks of study particpation ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) [ Time Frame: during week 8 or last week of study participation ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: March 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam
Levetiracetam 1500 mg BID
Drug: levetiracetam
Levetiracetam 1500 mg BID
Other Name: keppra

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141115

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
UCB, Inc.
Investigators
Principal Investigator: Frances R Levin, MD New York State Psychiatric Institute
  More Information

Additional Information:
No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00141115     History of Changes
Other Study ID Numbers: 4773
Study First Received: August 31, 2005
Last Updated: December 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Substance-induced anxiety disorder

Additional relevant MeSH terms:
Alcoholism
Anxiety Disorders
Panic Disorder
Phobic Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014