CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 3 enrolled
Drug / intervention
levetiracetamdrug
Likely dose
Levetiracetam 1500 mg orally twice dailyAI-extracted
Key inclusion· 5
  • ✓Age 18-65 with DSM-IV alcohol dependence AND a comorbid anxiety disorder (panic disorder, social phobia, generalized anxiety disorder, substance-induced anxiety disorder, or anxiety disorder NOS)
  • ✓Clinically significant anxiety symptoms
  • ✓Current heavy alcohol use: >4 drinking days per week AND >4 standard drinks/drinking day (women) or >5 (men) over past 28 days
  • ✓Capable of informed consent and study compliance
Key exclusion· 10
  • ✕Current Axis I psychiatric disorder (other than alcohol dependence and allowed anxiety disorders) requiring pharmacological intervention; specifically excludes PTSD and OCD
  • ✕Moderate to severe alcohol withdrawal requiring pharmacologic intervention
  • ✕Current cocaine or opioid dependence (DSM-IV criteria)
  • ✕Unstable physical disorders: uncontrolled hypertension (SBP >150, DBP >90), tachycardia (HR >100 bpm), acute hepatitis, or poorly controlled diabetes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00141115
NCT00141115Phase 2Completed
CompareCT.gov

Pilot Trial of Levetiracetam in the Treatment of Alcohol Dependence With Comorbid Anxiety

New York State Psychiatric Institute·interventional·Posted Sep 1, 2005·Updated Apr 24, 2019

In Brief

A Phase 2 clinical trial evaluating levetiracetam for Alcoholism and 4 related conditions. Completed, enrolled 3 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcoholism, Generalized Anxiety Disorder, Panic Disorder, Social Phobia, Anxiety Disorders
CountriesUnited States
CollaboratorsUCB Pharma

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2005
Enrollment StartMar 1, 2004
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.8 years ago

Interventions

levetiracetamdrug

Levetiracetam 1500 mg BID