NCT00630955

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

March 5, 2014

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

4.9 years

First QC Date

February 27, 2008

Results QC Date

August 19, 2013

Last Update Submit

March 5, 2020

Conditions

Keywords

Alcohol DrinkingMemantine

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

EXPERIMENTAL

20 mg memantine

Drug: memantine

2

EXPERIMENTAL

40 mg memantine

Drug: Memantine

3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Memantine 20 mg once per day for 7 days

Also known as: Namenda
1

Placebo once per day for 7 days

3

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

Related Links

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Memantine

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Suchitra Krishnan-Sarin, Associate Professor of Psychiatry
Organization
Yale University

Study Officials

  • Suchitra Krishnan-Sarin, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

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

Locations