Naltrexone and Memantine Effects on Alcohol Drinking Behaviors
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01519063 |
Recruitment Status :
Completed
First Posted : January 26, 2012
Results First Posted : July 10, 2019
Last Update Posted : March 9, 2020
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcohol Drinking | Drug: Naltrexone and memantine first Drug: Naltrexone and Placebo first | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Naltrexone and memantine
Treatment with Naltrexone and memantine first
|
Drug: Naltrexone and memantine first
Naltrexone 50mg memantine 20mg
Other Names:
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:
Drug: Naltrexone and Placebo first Naltrexone 50 mg Placebo
Other Name: naltrexone's brand name is Revia |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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.
Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Connecticut | |
Sac, Cmhc | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Suchitra Krishnan-Sarin, Ph.D. | Yale University |
Documents provided by Yale University:
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 |
Alcohol Drinking Drinkers Alcohol Drinking Memantine Naltrexone |
Alcohol Dependence Alcohol Abuse Alcohol-Related Disorders Ethanol Alcoholism |
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 |