Levetiracetam for the Treatment of Alcohol Dependence and Anxiety
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00141115 |
Recruitment Status :
Completed
First Posted : September 1, 2005
Results First Posted : September 15, 2017
Last Update Posted : April 24, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcoholism Generalized Anxiety Disorder Panic Disorder Social Phobia Anxiety Disorders | Drug: levetiracetam | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Trial of Levetiracetam in the Treatment of Alcohol Dependence With Comorbid Anxiety |
Study Start Date : | March 2004 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Levetiracetam
Levetiracetam 1500 mg BID
|
Drug: levetiracetam
Levetiracetam 1500 mg BID
Other Name: keppra |
- Participants Who Reported Reductions in Alcohol Consumption [ Time Frame: over 9 weeks of study or length of participation ]Number of participants who reduced drinking during the trial
- Percent of Drinking Days [ Time Frame: 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141115
United States, New York | |
New York State Psychiatric Institute | |
New York, New York, United States, 10032 |
Principal Investigator: | Frances R Levin, MD | New York State Psychiatric Institute |
Responsible Party: | John Mariani MD, research psychiatrist, New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT00141115 |
Other Study ID Numbers: |
4773 |
First Posted: | September 1, 2005 Key Record Dates |
Results First Posted: | September 15, 2017 |
Last Update Posted: | April 24, 2019 |
Last Verified: | April 2019 |
Substance-induced anxiety disorder |
Disease Alcoholism Anxiety Disorders Panic Disorder Phobia, Social Pathologic Processes Mental Disorders |
Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Phobic Disorders Levetiracetam Anticonvulsants Nootropic Agents |