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Family History Study of Alcohol Consumption Using Memantine

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ClinicalTrials.gov Identifier: NCT00630955
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : March 5, 2014
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Alcohol Drinking Drug: memantine Drug: Memantine Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: NMDA Antagonist Efficacy in Reducing Human Alcohol Consumption: Impact of Family History
Study Start Date : June 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Drinks Consumed on Day 7 [ Time Frame: Day 7 ]
  2. 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 :
  1. Stimulation Responses to Alcohol [ Time Frame: Day 7 ]
    Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol on Day 7, 6 items, 11-point rating scale from 0=Not at All to 10=Extremely, total scores ranging from 0 - 30, with higher measurements indicating higher stimulation.

  2. Sedation Responses to Alcohol [ Time Frame: Day 7 ]
    Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol on Day 7, 6 items, 11-point rating scale from 0=Not at All to 10=Extremely, total scores ranging from 0 - 30, with higher measurements indicating higher sedation.


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

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00630955    
Other Study ID Numbers: 0602001068
P50AA012870 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2008    Key Record Dates
Results First Posted: March 5, 2014
Last Update Posted: March 17, 2020
Last Verified: March 2020
Keywords provided by Yale University:
Alcohol Drinking
Memantine
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents