Naltrexone and Memantine Effects on Alcohol Drinking Behaviors

March 5, 2020 updated by: Yale University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Sac, Cmhc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • naltrexone's brand name is Revia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 7
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.
50-230 minutes after the priming drink during lab session
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.
50-230 minutes after the priming drink during lab session
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.
50-230 minutes after the priming drink during lab session
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.
0-50 minutes after the priming drink
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.
0-50 minutes after priming drink
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.
0-50 minutes after priming drink

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

March 29, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (Estimate)

January 26, 2012

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1005006779
  • P50AA012870 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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