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Family History Study of Alcohol Consumption Using Memantine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00630955
First Posted: March 7, 2008
Last Update Posted: November 7, 2016
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.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Suchitra Krishnan-Sarin, Yale University
  Purpose
The purpose of this study is to evaluate the effects of the study medication, memantine (placebo, 20 mg or 40 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. We hypothesize that memantine will reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period. We will also evaluate the influence of family history of alcoholism on the efficacy of memantine in reducing alcohol drinking behavior.

Condition Intervention Phase
Alcohol Drinking Drug: memantine Drug: Memantine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: NMDA Antagonist Efficacy in Reducing Human Alcohol Consumption: Impact of Family History

Resource links provided by NLM:


Further study details as provided by Suchitra Krishnan-Sarin, Yale University:

Primary Outcome Measures:
  • Number of Drinks Consumed on Day 7 [ Time Frame: Day 7 ]
  • Baseline-adjusted Craving (YCS) [ Time Frame: Day 7 ]
    Craving for alcohol based on Yale Craving Scale, scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7.


Secondary Outcome Measures:
  • Stimulation and Sedation Responses to Alcohol [ Time Frame: Day 7 ]

Enrollment: 111
Study Start Date: June 2006
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
20 mg memantine
Drug: memantine
Memantine 20 mg once per day for 7 days
Other Name: Namenda
Experimental: 2
40 mg memantine
Drug: Memantine
Memantine 40 mg once per day for 7 days
Other Name: Namenda
Placebo Comparator: 3 Drug: Placebo
Placebo once per day for 7 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 21-50
  • Able to read English at 6th grade level or higher and to complete study evaluations
  • Regular alcohol drinker

Exclusion Criteria:

  • Individuals who are seeking alcohol treatment
  • Medical conditions that would contraindicate the use of memantine
  • Regular use of other substances
  Contacts and Locations
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): NCT00630955


Locations
United States, Connecticut
CMHC
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale School of Medicine
  More Information

Additional Information:
Responsible Party: Suchitra Krishnan-Sarin, Associate Professor, Department of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT00630955     History of Changes
Other Study ID Numbers: 0602001068
P50AA012870 ( U.S. NIH Grant/Contract )
First Submitted: February 27, 2008
First Posted: March 7, 2008
Results First Submitted: August 19, 2013
Results First Posted: March 5, 2014
Last Update Posted: November 7, 2016
Last Verified: November 2016

Keywords provided by Suchitra Krishnan-Sarin, Yale University:
Alcohol Drinking
Memantine

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
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