Family History Study of Alcohol Consumption Using Memantine

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Suchitra Krishnan-Sarin, Yale University
ClinicalTrials.gov Identifier:
NCT00630955
First received: February 27, 2008
Last updated: January 17, 2014
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Yale University:

Primary Outcome Measures:
  • Number of Drinks Consumed on Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Baseline-adjusted Craving (YCS) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630955

Locations
United States, Connecticut
CMHC
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale School of Medicine
  More Information

Additional Information:
No publications provided

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
Study First Received: February 27, 2008
Results First Received: August 19, 2013
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Alcohol Drinking
Memantine

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Memantine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014