Family History Study of Alcohol Consumption Using Memantine

Phase 2

Completed

• Conditions: Alcohol Drinking
• Interventions: Drug: Memantine; Drug: Placebo

• Registration Number: NCT00630955
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-02-27
• Study First Posted: 2008-03-07
• Primary Completion: 2011-05
• Study Completion: 2011-08
• Results First Submitted: 2013-08-19
• Results First Submitted QC: 2014-01-17
• Results First Posted: 2014-03-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Memantine	20 mg memantine
3	Placebo	-
2	Memantine	40 mg memantine

Primary Outcome Measures

Name	Time	Method
Baseline-adjusted Craving (YCS)	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.
Number of Drinks Consumed on Day 7	Day 7

Secondary Outcome Measures

Name	Time	Method
Stimulation Responses to Alcohol	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.
Sedation Responses to Alcohol	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.

Trial Locations

Locations (1)

CMHC; 🇺🇸 New Haven, Connecticut, United States