Naltrexone and Memantine Effects on Alcohol Drinking Behaviors

NCT ID: NCT01519063

Last Updated: 2020-03-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-05-01

Brief Summary

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The purpose of this study is to evaluate the combined effects of the study medications naltrexone and memantine on alcohol drinking behaviors.

Detailed Description

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Participants will be randomized to receive a combination of naltrexone/memantine over a one week period and then participate in a laboratory session. During this session, participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. These medications are hypothesized to 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.

Conditions

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Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Naltrexone and memantine

Treatment with Naltrexone and memantine first

Group Type EXPERIMENTAL

Naltrexone and memantine first

Intervention Type DRUG

Naltrexone 50mg memantine 20mg

Naltrexone and Placebo first

Intervention Type DRUG

Naltrexone 50 mg Placebo

Naltrexone and Placebo

Treatment with naltrexone and placebo first

Group Type PLACEBO_COMPARATOR

Naltrexone and memantine first

Intervention Type DRUG

Naltrexone 50mg memantine 20mg

Naltrexone and Placebo first

Intervention Type DRUG

Naltrexone 50 mg Placebo

Interventions

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Naltrexone and memantine first

Naltrexone 50mg memantine 20mg

Intervention Type DRUG

Naltrexone and Placebo first

Naltrexone 50 mg Placebo

Intervention Type DRUG

Other Intervention Names

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memantine's brand name is Namenda naltrexone's brand name is Revia naltrexone's brand name is Revia

Eligibility Criteria

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Inclusion Criteria

* Ages 21-55
* 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 study medication
* Regular use of other substances
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suchitra Krishnan-Sarin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Sac, Cmhc

New Haven, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P50AA012870

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1005006779

Identifier Type: -

Identifier Source: org_study_id

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