Alcohol Drinking
Conditions
Keywords
Alcohol Drinking, Memantine
Brief summary
The purpose of this study is to evaluate the effects of the study medication, memantine (placebo, 20 mg or 40 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. We hypothesize that memantine will 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. We will also evaluate the influence of family history of alcoholism on the efficacy of memantine in reducing alcohol drinking behavior.
Interventions
DRUGmemantine
Memantine 20 mg once per day for 7 days
DRUGMemantine
Memantine 40 mg once per day for 7 days
DRUGPlacebo
Placebo once per day for 7 days
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Ages 21-50 * 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 memantine * Regular use of other substances
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Drinks Consumed on Day 7 | Day 7 | — |
| Baseline-adjusted Craving (YCS) | Day 7 | Craving for alcohol based on Yale Craving Scale, scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stimulation Responses to Alcohol | Day 7 | Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol on Day 7, 6 items, 11-point rating scale from 0=Not at All to 10=Extremely, total scores ranging from 0 - 30, with higher measurements indicating higher stimulation. |
| Sedation Responses to Alcohol | Day 7 | Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol on Day 7, 6 items, 11-point rating scale from 0=Not at All to 10=Extremely, total scores ranging from 0 - 30, with higher measurements indicating higher sedation. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from May 2006-May 2011 using posted advertisements in the local newspaper and brochures and other materials distributed in the community (bars, coffee shops, grocery stores).Electronic media and social networking were also used, including Craigslist and Facebook.
Participants by arm
| Arm | Count |
|---|---|
| 0 mg Memantine | 34 |
| 20 mg Memantine | 37 |
| 40 mg Memantine | 40 |
| Total | 111 |
Baseline characteristics
| Characteristic | 20 mg Memantine | 40 mg Memantine | 0 mg Memantine | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 40 Participants | 34 Participants | 111 Participants |
| Age, Continuous | 32.4 years STANDARD_DEVIATION 9.3 | 31.3 years STANDARD_DEVIATION 8.8 | 29.1 years STANDARD_DEVIATION 7.2 | 31.0 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment United States | 37 participants | 40 participants | 34 participants | 111 participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 11 Participants | 36 Participants |
| Sex: Female, Male Male | 25 Participants | 27 Participants | 23 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 22 / 34 | 24 / 37 | 31 / 40 |
| serious Total, serious adverse events | 0 / 34 | 0 / 37 | 0 / 40 |
Outcome results
Primary
Baseline-adjusted Craving (YCS)
Craving for alcohol based on Yale Craving Scale, scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7.
Time frame: Day 7
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 0 mg Memantine | Baseline-adjusted Craving (YCS) | 20.2 millimeters | Standard Error 2.16 |
| 20 mg Memantine | Baseline-adjusted Craving (YCS) | 14.1 millimeters | Standard Error 2.23 |
| 40 mg Memantine | Baseline-adjusted Craving (YCS) | 21.4 millimeters | Standard Error 2.23 |
Primary
Number of Drinks Consumed on Day 7
Time frame: Day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 mg Memantine | Number of Drinks Consumed on Day 7 | 5.84 standard drinks | Standard Deviation 3.67 |
| 20 mg Memantine | Number of Drinks Consumed on Day 7 | 5.61 standard drinks | Standard Deviation 4.6 |
| 40 mg Memantine | Number of Drinks Consumed on Day 7 | 6.21 standard drinks | Standard Deviation 4.61 |
Secondary
Sedation Responses to Alcohol
Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol on Day 7, 6 items, 11-point rating scale from 0=Not at All to 10=Extremely, total scores ranging from 0 - 30, with higher measurements indicating higher sedation.
Time frame: Day 7
Population: Analysis includes all those who had complete data, which is less than those listed in the Participant Flow module
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 mg Memantine | Sedation Responses to Alcohol | 3.286 units on a scale | Standard Deviation 5.381 |
| 20 mg Memantine | Sedation Responses to Alcohol | 3.964 units on a scale | Standard Deviation 6.327 |
| 40 mg Memantine | Sedation Responses to Alcohol | 3.37 units on a scale | Standard Deviation 5.085 |
Secondary
Stimulation Responses to Alcohol
Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol on Day 7, 6 items, 11-point rating scale from 0=Not at All to 10=Extremely, total scores ranging from 0 - 30, with higher measurements indicating higher stimulation.
Time frame: Day 7
Population: Analysis includes all those who had complete data, which is less than those listed in the Participant Flow module
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 mg Memantine | Stimulation Responses to Alcohol | 4.643 units on a scale | Standard Deviation 4.923 |
| 20 mg Memantine | Stimulation Responses to Alcohol | 4.321 units on a scale | Standard Deviation 5.313 |
| 40 mg Memantine | Stimulation Responses to Alcohol | 6.444 units on a scale | Standard Deviation 6.536 |