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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

January 23, 2012
June 18, 2014
January 2012
January 2017   (final data collection date for primary outcome measure)
number of drinks consumed [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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.
 
Recruiting
86
January 2017
January 2017   (final data collection date for primary outcome measure)

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
Both
21 Years to 50 Years
No
Contact: Nicholas Franco, B.A. 203 974-7679 nicholas.franco@yale.edu
Contact: Dana Cavallo, Ph.D. 203 974-7607 dana.cavallo@yale.edu
United States
 
NCT01519063
1005006779, P50AA012870
Yes
Yale University
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University
Yale University
June 2014

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