Naltrexone and Memantine Effects on Alcohol Drinking Behaviors

Yale University

Status and phase: Completed; Phase 2

Conditions: Alcohol Drinking

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01519063

P50AA012870 (U.S. NIH Grant/Contract)

1005006779

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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75 participants in 2 patient groups, including a placebo group

Naltrexone and memantine

Experimental group

Description:

Treatment with Naltrexone and memantine first

Treatment:

Drug: Naltrexone and memantine first

Drug: Naltrexone and Placebo first

Naltrexone and Placebo

Placebo Comparator group

Description:

Treatment with naltrexone and placebo first

Treatment:

Drug: Naltrexone and memantine first

Drug: Naltrexone and Placebo first