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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
  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: Participant, Care Provider, Investigator
Primary Purpose: Other
Official Title: Glutamate-opioid Interactions in Alcohol Drinking Behaviors

Resource links provided by NLM:


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 ( US NIH Grant/Contract Award Number )
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
Memantine
Naltrexone
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 23, 2017