Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P50AA012870 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 20 mg memantine |
|
| 2 | Experimental | 40 mg memantine |
|
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| memantine | Drug | Memantine 20 mg once per day for 7 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drinks Consumed on Day 7 | Day 7 | |
| 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. | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 7 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Suchitra Krishnan-Sarin, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMHC | New Haven | Connecticut | 06519 | United States |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 0 mg Memantine | Participants who received placebo PO qd |
| FG001 | 20 mg Memantine | Participants randomized to 20 mg memantine PO qd |
| FG002 | 40 mg Memantine | Participants randomized to 40mg memantine PO qd |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0 mg Memantine | |
| BG001 | 20 mg Memantine | |
| BG002 | 40 mg Memantine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Drinks Consumed on Day 7 | Posted | Mean | Standard Deviation | standard drinks | Day 7 |
|
Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0 mg | Participants who received placebo |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suchitra Krishnan-Sarin, Associate Professor of Psychiatry | Yale University | 203-974-7595 | suchitra.krishnan-sarin@yale.edu |
Not provided
| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Memantine | Drug | Memantine 40 mg once per day for 7 days |
|
|
| Placebo | Drug | Placebo once per day for 7 days |
|
| 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. |
| Day 7 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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. | Posted | Least Squares Mean | Standard Error | millimeters | Day 7 |
|
|
|
| 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. | Analysis includes all those who had complete data, which is less than those listed in the Participant Flow module | Posted | Mean | Standard Deviation | units on a scale | Day 7 |
|
|
|
| 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. | Analysis includes all those who had complete data, which is less than those listed in the Participant Flow module | Posted | Mean | Standard Deviation | units on a scale | Day 7 |
|
|
|
| 0 |
| 34 |
| 22 |
| 34 |
| EG001 | 20 mg | Participants randomized to 20 mg memantine | 0 | 37 | 24 | 37 |
| EG002 | 40 mg | Participants randomized to 40mg memantine | 0 | 40 | 31 | 40 |
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| vomit | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Dizzy | Nervous system disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| nervous | Psychiatric disorders | Non-systematic Assessment |
|
| insomnia | Nervous system disorders | Non-systematic Assessment |
|
| confusion | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |