Naltrexone and Memantine Effects on Alcohol Drinking Behaviors

Alcohol Drinking Clinical Trial

Official title:

Glutamate-opioid Interactions in Alcohol Drinking Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519063
• Other study ID #: 1005006779
• Secondary ID: P50AA012870
• Status: Completed
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: May 1, 2017

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 1, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Drinking Behavior

Intervention

Drug:
• Naltrexone and memantine first
Naltrexone 50mg memantine 20mg
• Naltrexone and Placebo first
Naltrexone 50 mg Placebo

Locations

Country	Name	City	State
United States	Sac, Cmhc	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Drinks Consumed at Lab Session (Day 7)	Number of drinks consumed during the lab session (Day 7) after taking study medication, ranging from 0-12.	Day 7
Primary	Craving AUC: Adlib Drinking Phase	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
Primary	Stimulation Response to Alcohol at 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
Primary	Sedation Response to Alcohol at 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
Primary	Craving AUC: Priming Dose Phase	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
Primary	Sedation Response to Alcohol: Priming Dose Phase	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
Primary	Stimulation Response to Alcohol: Priming Dose Phase	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