Family History Study of Alcohol Consumption Using Memantine
NMDA Antagonist Efficacy in Reducing Human Alcohol Consumption: Impact of Family History
2 other identifiers
interventional
111
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 27, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
March 5, 2014
CompletedMarch 17, 2020
March 1, 2020
4.9 years
February 27, 2008
August 19, 2013
March 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Drinks Consumed on Day 7
Day 7
Baseline-adjusted Craving (YCS)
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.
Day 7
Secondary Outcomes (2)
Stimulation Responses to Alcohol
Day 7
Sedation Responses to Alcohol
Day 7
Study Arms (3)
1
EXPERIMENTAL20 mg memantine
2
EXPERIMENTAL40 mg memantine
3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Ages 21-50
- Able to read English at 6th grade level or higher and to complete study evaluations
- Regular alcohol drinker
You may not qualify if:
- Individuals who are seeking alcohol treatment
- Medical conditions that would contraindicate the use of memantine
- Regular use of other substances
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CMHC
New Haven, Connecticut, 06519, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Suchitra Krishnan-Sarin, Associate Professor of Psychiatry
- Organization
- Yale University
Study Officials
- PRINCIPAL INVESTIGATOR
Suchitra Krishnan-Sarin, Ph.D.
Yale University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2008
First Posted
March 7, 2008
Study Start
June 1, 2006
Primary Completion
May 1, 2011
Study Completion
August 1, 2011
Last Updated
March 17, 2020
Results First Posted
March 5, 2014
Record last verified: 2020-03