Naltrexone and Memantine Effects on Alcohol Drinking Behaviors

NCT01519063 | Completed Phase 2 Results DMC

• 2 other identifiers: 1005006779P50AA012870
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcohol Drinking

Keywords

Alcohol; Drinking; Drinkers; Alcohol Drinking; Memantine; Naltrexone; Alcohol Dependence; Alcohol Abuse; Alcohol-Related Disorders; Ethanol; Alcoholism

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Naltrexone and memantine

EXPERIMENTAL

Treatment with Naltrexone and memantine first

Drug: Naltrexone and memantine first; Drug: Naltrexone and Placebo first

Naltrexone and Placebo

PLACEBO COMPARATOR

Treatment with naltrexone and placebo first

Drug: Naltrexone and memantine first; Drug: Naltrexone and Placebo first

Interventions

Naltrexone and memantine first DRUG

Naltrexone 50mg memantine 20mg

Also known as: memantine's brand name is Namenda, naltrexone's brand name is Revia

Naltrexone and Placebo; Naltrexone and memantine

Naltrexone and Placebo first DRUG

Naltrexone 50 mg Placebo

Also known as: naltrexone's brand name is Revia

Naltrexone and Placebo; Naltrexone and memantine

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 21-55
• Able to read English at 6th grade level or higher and to complete study evaluations
• Regular alcohol drinker

You may not qualify if:

• Individuals who are seeking alcohol treatment
• Medical conditions that would contraindicate the use of study medication
• Regular use of other substances

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Sac, Cmhc

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism; Alcohol-Related Disorders

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dana Cavallo, Assistant Professor
• Organization: Yale University

dana.cavallo@yale.edu

203974-7607

Study Officials

• Suchitra Krishnan-Sarin, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 26, 2012
• Study Start: January 1, 2012
• Primary Completion: March 29, 2017
• Study Completion: May 1, 2017
• Last Updated: March 9, 2020
• Results First Posted: July 10, 2019

Record last verified: 2020-03

Locations

US (1)