A Placebo-Controlled Trial of Memantine for Alcohol Dependence

This study has been completed.
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00246415
First received: October 27, 2005
Last updated: October 7, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Alcohol Dependence (Primary Condition)
Alcohol Abuse
Drug: Memantine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Medications Development for Alcohol Abuse: NMDA Agents -- A Placebo-Controlled Trial of Memantine for Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

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: 90
Study Start Date: November 2002
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246415

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Investigators
Principal Investigator: Suzette M. Evans, PhD New York State Psychiatric Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00246415     History of Changes
Other Study ID Numbers: NIAAA-EVA12599, NIH RO1 AA12599
Study First Received: October 27, 2005
Last Updated: October 7, 2008
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 16, 2013