N/A
Completed N=46
Effects of Levetiracetam (Keppra) on Alcohol Consumption
Alcohol Abuse · Drug Abuse
Source: ClinicalTrials.gov NCT01168687 ↗
Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: Standard Alcoholic Drinks Per Treatment Period — 41.2; 45.4 number of drinks per treatment period
Summary
The overall goals of this study are to (1) expand knowledge about interactions of levetiracetam with alcohol by assessing the effects of levetiracetam compared to placebo in moderate and heavy social alcohol users and (2) to test the AccuswayTM platform as a tool to measure postural control (which has been used as a marker of intoxication) and the effects of levetiracetam on postural control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standard Alcoholic Drinks Per Treatment Period |
41.2; 45.4 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy adults who are social drinkers 21 and 50 years of age.
- Moderate to heavy social drinkers (women=7-21 drinks/week, men=7-25 drinks/week).
- Body Mass Index (BMI)>18 and 5 standard drinks in one session).
- Alcohol consumption >21 drinks/week for women and >25 drinks/week for men.
- Currently trying to quit alcohol and/or recreational drug use.
- Positive for lifetime abnormal opioid use or prescription drug abuse.
- Clinically significant medical or psychiatric illness (including anxiety or panic disorders) as determined by screening blood tests, medical history, and physical exam performed or reviewed by the study physician.
- Bilirubin more than 2 times the normal upper limit.
- AST (SGOT), ALT (SGPT), or alkaline phosphatase more than 2 times the normal upper limit.
- Body Mass Index >30 or 480 m secs at baseline.
- Has received an investigational drug within 30 days prior to Study Visit 2 (after screening visit).
- Subjects who are unable to read or speak English.
- Those, in the opinion of the investigator, who are considered unable to adhere to scheduled appointments, unlikely to comply with the study protocol, or who are unsuitable for any other reason.
Data sourced from ClinicalTrials.gov (NCT01168687). 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.