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Naltrexone and Memantine Effects on Alcohol Drinking Behaviors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01519063
First Posted: January 26, 2012
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University
January 23, 2012
January 26, 2012
May 17, 2017
January 2012
March 29, 2017   (Final data collection date for primary outcome measure)
number of drinks consumed [ Time Frame: 1 month ]
Same as current
Complete list of historical versions of study NCT01519063 on ClinicalTrials.gov Archive Site
Stimulation and sedation responses to alcohol [ Time Frame: 1 month ]
Same as current
Not Provided
Not Provided
 
Naltrexone and Memantine Effects on Alcohol Drinking Behaviors
Glutamate-opioid Interactions in Alcohol Drinking Behaviors
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Alcohol Drinking
  • Drug: Naltrexone and memantine
    Naltrexone 50mg memantine 20mg
    Other Names:
    • memantine's brand name is Namenda
    • naltrexone's brand name is Revia
  • Drug: Naltrexone and Placebo
    Naltrexone 50 mg Placebo
  • Experimental: Naltrexone and memantine
    Treatment with Naltrexone and memantine
    Intervention: Drug: Naltrexone and memantine
  • Placebo Comparator: Naltrexone and Placebo
    Treatment with naltrexone and placebo
    Intervention: Drug: Naltrexone and Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
May 1, 2017
March 29, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01519063
1005006779
P50AA012870 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Yale University
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University
Yale University
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP