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Naltrexone and Memantine Effects on Alcohol Drinking Behaviors

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ClinicalTrials.gov Identifier: NCT01519063
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Alcohol Drinking Drug: Naltrexone and memantine Drug: Naltrexone and Placebo Phase 2

Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Glutamate-opioid Interactions in Alcohol Drinking Behaviors
Actual Study Start Date : January 2012
Actual Primary Completion Date : March 29, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. number of drinks consumed [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Stimulation and sedation responses to alcohol [ Time Frame: 1 month ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01519063     History of Changes
Other Study ID Numbers: 1005006779
P50AA012870 ( U.S. NIH Grant/Contract )
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 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