Naltrexone and Memantine Effects on Alcohol Drinking Behaviors

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01519063
First received: January 23, 2012
Last updated: June 18, 2014
Last verified: June 2014
  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:


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 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 21-50
  • 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
Investigators
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University
  More Information

No publications provided

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: June 18, 2014
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
Naltrexone
Memantine
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
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 16, 2014