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
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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:
- 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.
Exclusion Criteria:
- 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.
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