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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
Results First Posted : July 10, 2019
Last Update Posted : March 9, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
The purpose of this study is to evaluate the combined effects of the study medications naltrexone and memantine on alcohol drinking behaviors.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Drug: Naltrexone and memantine first Drug: Naltrexone and Placebo first Phase 2

Detailed Description:
Participants will be randomized to receive a combination of naltrexone/memantine 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.
Study Design
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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

Arms and Interventions
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Arm Intervention/treatment
Experimental: Naltrexone and memantine
Treatment with Naltrexone and memantine first
 Drug: Naltrexone and memantine first
Naltrexone 50mg memantine 20mg
Other Names:
  • memantine's brand name is Namenda
  • naltrexone's brand name is Revia

Drug: Naltrexone and Placebo first
Naltrexone 50 mg Placebo
Other Name: naltrexone's brand name is Revia
Placebo Comparator: Naltrexone and Placebo
Treatment with naltrexone and placebo first
 Drug: Naltrexone and memantine first
Naltrexone 50mg memantine 20mg
Other Names:
  • memantine's brand name is Namenda
  • naltrexone's brand name is Revia

Drug: Naltrexone and Placebo first
Naltrexone 50 mg Placebo
Other Name: naltrexone's brand name is Revia


Outcome Measures
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Primary Outcome Measures :
  1. Number of Drinks Consumed at Lab Session (Day 7) [ Time Frame: Day 7 ]
    Number of drinks consumed during the lab session (Day 7) after taking study medication, ranging from 0-12.

  2. Craving AUC: Adlib Drinking Phase [ Time Frame: 50-230 minutes after the priming drink during lab session ]
    Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher craving scores (ranging from 0-56) are indicated by larger log-transformed AUC.

  3. Stimulation Response to Alcohol at Lab Session [ Time Frame: 50-230 minutes after the priming drink during lab session ]
    Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher stimulation scores (ranging from 0-70) are indicated by larger log-transformed AUC.

  4. Sedation Response to Alcohol at Lab Session [ Time Frame: 50-230 minutes after the priming drink during lab session ]

    Brief Biphasic Alcohol Effects Scale-Sedation subscale (BAES; Martin et al., 1993), measuring sedation effects of alcohol. The seven items included on the sedation subscale range from 1 (not at all) to extremely (10) with higher measurements indicating higher sedation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Area Under the Curve was used to calculate the final score reported for the BAES.

    As a single summary measure, AUC, was calculated for BAES outcomes based on scores recorded at numerous time points throughout the adlib drinking session The calculation was based on the trapezoidal methods using times 50, 90, 110, 150, 170, 210, and 230 . Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater levels of sedation.


  5. Craving AUC: Priming Dose Phase [ Time Frame: 0-50 minutes after the priming drink ]
    Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Craving for alcohol based on Alcohol Urge Questionnaire is calculated using Area Under the Curve (AUC). A single summary measure, AUC was calculated for AUQ outcomes based on scores recorded at numerous time points throughout the priming drink session. The calculation was based on the trapezoidal methods using times -20, 10, 20, 30, 40, 50 minutes before/after priming drink. Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater alcohol urge.

  6. Sedation Response to Alcohol: Priming Dose Phase [ Time Frame: 0-50 minutes after priming drink ]
    Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol with higher measurements indicating higher sedation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.

  7. Stimulation Response to Alcohol: Priming Dose Phase [ Time Frame: 0-50 minutes after priming drink ]
    Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol with higher measurements indicating higher stimulation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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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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
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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
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Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University
  Study Documents (Full-Text)

Documents provided by Yale University:
Study Protocol and Statistical Analysis Plan  [PDF] December 7, 2016

More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01519063    
Other Study ID Numbers: 1005006779
P50AA012870 ( U.S. NIH Grant/Contract )
First Posted: January 26, 2012    Key Record Dates
Results First Posted: July 10, 2019
Last Update Posted: March 9, 2020
Last Verified: March 2020
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:
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Alcohol Drinking
Drinking Behavior
Naltrexone
Memantine
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
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