A Placebo-Controlled Trial of Memantine for Alcohol Dependence
This study has been completed.
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First received: October 27, 2005
Last updated: October 7, 2008
Last verified: October 2008
The purpose of this study is to obtain a preliminary indication of the safety and effectiveness of oral memantine (40 mg/day) in alcohol dependent patients. This study is a 16-week study comparison of memantine and placebo in patients with alcohol dependence.
Alcohol Dependence (Primary Condition)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||Medications Development for Alcohol Abuse: NMDA Agents -- A Placebo-Controlled Trial of Memantine for Alcohol Dependence
Primary Outcome Measures:
- Alcohol consumption- Standard Drink Units (Time line Followback)
- Abstinence from alcohol (Time line Followback)
Secondary Outcome Measures:
- Clinical Global Impression-Alcohol
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2005 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Males or females between the ages of 18-65 yrs.
- Meets DSM-IV criteria for current alcohol dependence. Volunteers may meet criteria for other substance abuse, or dependence on other drugs (nicotine, marijuana or cocaine) as long as the dependence on marijuana or cocaine is secondary to alcohol dependence
- Medically healthy on the basis of physical examination and medical history, vital signs, ECG and laboratory tests, with a negative blood pregnancy test for females.
- Expresses desire to stop drinking alcohol.
- Does not require any psychotropic medication.
- Able to provide informed consent and comply with study procedures.
- Signed informed consent.
- Dependence on opiates
- Meets DSM-IV criteria for schizophrenia or bipolar Disorder. Has a psychotic illness or is at risk for suicidal behavior.
- History of delerium tremens (hallucinations, psychosis, agitation) secondary to alcohol withdrawal, a personal or family history of seizure disorder, a personal history of moderate/severe head trauma.
- Currently taking psychotropic medication.
- In need of inpatient alcohol detoxification.
- Any renal disease or insufficiency.
- Clinically significant and symptomatic medical disorder requiring active intervention
- Female patients who are lactating or who have childbearing potential and who refuse to use birth control (hormone or barrier) or are pregnant.
- Patients for whom treatment of alcoholism is being mandated by legal action.
- Patients with active malignancy (other than non- melanoma skin cancer of carcinoma in situ of uterine cervix) within 5 years of beginning study.
- Known or suspected hypersensitivity to memantine.
- Intolerable adverse event during Single Blind Placebo Lead-in Phase.
- Patients taking naltrexone or antabuse.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246415
|New York State Psychiatric Institute
|New York, New York, United States, 10032 |
||Suzette M. Evans, PhD
||New York State Psychiatric Institute
No publications provided
History of Changes
|Other Study ID Numbers:
||NIAAA-EVA12599, NIH RO1 AA12599
|Study First Received:
||October 27, 2005
||October 7, 2008
||United States: Federal Government
Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Anti-Infective Agents, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents