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A Placebo-Controlled Trial of Memantine for Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00246415
Recruitment Status : Completed
First Posted : October 31, 2005
Last Update Posted : October 8, 2008
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence (Primary Condition) Alcohol Abuse Drug: Memantine Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Medications Development for Alcohol Abuse: NMDA Agents -- A Placebo-Controlled Trial of Memantine for Alcohol Dependence
Study Start Date : November 2002
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Alcohol consumption- Standard Drink Units (Time line Followback)
  2. Abstinence from alcohol (Time line Followback)

Secondary Outcome Measures :
  1. Clinical Global Impression-Alcohol


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females between the ages of 18-65 yrs.
  2. 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
  3. 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.
  4. Expresses desire to stop drinking alcohol.
  5. Does not require any psychotropic medication.
  6. Able to provide informed consent and comply with study procedures.
  7. Signed informed consent.

Exclusion Criteria:

  1. Dependence on opiates
  2. Meets DSM-IV criteria for schizophrenia or bipolar Disorder. Has a psychotic illness or is at risk for suicidal behavior.
  3. 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.
  4. Currently taking psychotropic medication.
  5. In need of inpatient alcohol detoxification.
  6. Any renal disease or insufficiency.
  7. Clinically significant and symptomatic medical disorder requiring active intervention
  8. Female patients who are lactating or who have childbearing potential and who refuse to use birth control (hormone or barrier) or are pregnant.
  9. Patients for whom treatment of alcoholism is being mandated by legal action.
  10. Patients with active malignancy (other than non- melanoma skin cancer of carcinoma in situ of uterine cervix) within 5 years of beginning study.
  11. Known or suspected hypersensitivity to memantine.
  12. Intolerable adverse event during Single Blind Placebo Lead-in Phase.
  13. Patients taking naltrexone or antabuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246415


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Suzette M. Evans, PhD New York State Psychiatric Institute

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ClinicalTrials.gov Identifier: NCT00246415     History of Changes
Other Study ID Numbers: NIAAA-EVA12599
NIH RO1 AA12599
First Posted: October 31, 2005    Key Record Dates
Last Update Posted: October 8, 2008
Last Verified: October 2008

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Alcohol Dependence
Alcohol Abuse
Memantine
Alcohol Treatment

Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Memantine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents