Naltrexone and Memantine Effects on Alcohol Drinking Behaviors

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2016 by Yale University

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: August 23, 2016

Last verified: August 2016

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 Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Stimulation and sedation responses to alcohol [ Time Frame: 1 month ] [ Designated as safety issue: No ]


Estimated Enrollment:	86
Study Start Date:	January 2012
Estimated Study Completion Date:	January 2017
Estimated Primary Completion Date:	January 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)
Genders Eligible for Study:	Both
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

Contacts


Contact: Nicholas Franco, B.A.	203 974-7679	nicholas.franco@yale.edu
Contact: Dana Cavallo, Ph.D.	203 974-7607	dana.cavallo@yale.edu

Locations


United States, Connecticut
Sac, Cmhc	Recruiting
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
Study First Received:	January 23, 2012
Last Updated:	August 23, 2016
Health Authority:	United States: Institutional Review Board United States: Federal Government

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 September 27, 2016

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