Phase 2
Completed N=3
Levetiracetam for the Treatment of Alcohol Dependence and Anxiety
Alcoholism · Anxiety · Panic Disorder · Social Phobia
Source: ClinicalTrials.gov NCT00141115 ↗
Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Participants Who Reported Reductions in Alcohol Consumption — 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Reported Reductions in Alcohol Consumption |
3 | — |
| SECONDARY Percent of Drinking Days |
67.9; 27.6 | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT00141115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.