Levetiracetam for the Treatment of Alcohol Dependence and Anxiety

NCT00141115 | Completed Phase 2 Results

• 1 other identifier: 4773
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcoholism; Generalized Anxiety Disorder; Panic Disorder; Social Phobia; Anxiety Disorders

Keywords

Substance-induced anxiety disorder

Outcome Measures

Primary Outcomes (1)

• Participants Who Reported Reductions in Alcohol Consumption

  Number of participants who reduced drinking during the trial

  over 9 weeks of study or length of participation

Secondary Outcomes (1)

• Percent of Drinking Days

  assessed daily, reported for baseline 28 days compared to last 28 days of study participation

Study Arms (1)

Levetiracetam

EXPERIMENTAL

Levetiracetam 1500 mg BID

Drug: levetiracetam

Interventions

levetiracetam DRUG

Levetiracetam 1500 mg BID

Also known as: keppra

Levetiracetam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• UCB Pharma: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

• STARS clinic website

MeSH Terms

Conditions

Alcoholism; Generalized Anxiety Disorder; Panic Disorder; Phobia, Social; Anxiety Disorders

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

poor recruitment leading to small number of participants in the analysis.

Results Point of Contact

• Title: John J. Mariani
• Organization: New York State Psychiatric Institute

jm2330@columbia.edu

2125435987

Study Officials

• Frances R Levin, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research psychiatrist

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 1, 2005
• Study Start: March 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: April 24, 2019
• Results First Posted: September 15, 2017

Record last verified: 2019-04

Locations

US (1)