Naltrexone and Memantine Effects on Alcohol Drinking Behaviors

This study has been completed.

Sponsor:

Collaborator:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Information provided by (Responsible Party):

Yale University

ClinicalTrials.gov Identifier:

NCT01519063

First received: January 23, 2012

Last updated: May 16, 2017

Last verified: May 2017

History of Changes

Purpose

The purpose of this study is to evaluate the combined effects of the study medications naltrexone and memantine on alcohol drinking behaviors. Participants will be randomized to receive a combination of these medications 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.

Condition	Intervention	Phase
Alcohol Drinking	Drug: Naltrexone and memantine Drug: Naltrexone and Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Other
Official Title:	Glutamate-opioid Interactions in Alcohol Drinking Behaviors

Resource links provided by NLM:

MedlinePlus related topics: Alcohol

Drug Information available for: Naltrexone Naltrexone hydrochloride Memantine Memantine hydrochloride

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

number of drinks consumed [ Time Frame: 1 month ]

Secondary Outcome Measures:

Stimulation and sedation responses to alcohol [ Time Frame: 1 month ]


Enrollment:	75
Actual Study Start Date:	January 2012
Study Completion Date:	May 1, 2017
Primary Completion Date:	March 29, 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Naltrexone and memantine Treatment with Naltrexone and memantine	Drug: Naltrexone and memantine Naltrexone 50mg memantine 20mg Other Names: memantine's brand name is Namenda naltrexone's brand name is Revia
Placebo Comparator: Naltrexone and Placebo Treatment with naltrexone and placebo	Drug: Naltrexone and Placebo Naltrexone 50 mg Placebo

Eligibility


Ages Eligible for Study:	21 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519063

Locations


United States, Connecticut
Sac, Cmhc
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators


Principal Investigator:	Suchitra Krishnan-Sarin, Ph.D.	Yale University

More Information


Responsible Party:	Yale University
ClinicalTrials.gov Identifier:	NCT01519063 History of Changes
Other Study ID Numbers:	1005006779 P50AA012870 ( U.S. NIH Grant/Contract )
Study First Received:	January 23, 2012
Last Updated:	May 16, 2017

Keywords provided by Yale University:


Alcohol Drinking Drinkers Alcohol Drinking Memantine Naltrexone	Alcohol Dependence Alcohol Abuse Alcohol-Related Disorders Ethanol Alcoholism

Additional relevant MeSH terms:


Alcohol Drinking Drinking Behavior Ethanol Naltrexone Memantine Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs Narcotic Antagonists	Sensory System Agents Peripheral Nervous System Agents Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on August 23, 2017

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