Family History Study of Alcohol Consumption Using Memantine
This study has been completed.
Sponsor:
Yale University
Collaborator:
Information provided by (Responsible Party):
Suchitra Krishnan-Sarin, Yale University
ClinicalTrials.gov Identifier:
NCT00630955
First received: February 27, 2008
Last updated: July 2, 2012
Last verified: June 2012
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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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Stimulation and sedation responses to alcohol [ Time Frame: 7 days ] [ 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 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 |
| Last Updated: | July 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
Alcohol Drinking Memantine |
Additional relevant MeSH terms:
|
Alcohol Drinking Drinking Behavior Memantine Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013