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Family History Study of Alcohol Consumption Using Memantine

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ClinicalTrials.gov Identifier: NCT00630955
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : March 5, 2014
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Other
Condition Alcohol Drinking
Interventions Drug: memantine
Drug: Memantine
Drug: Placebo
Enrollment 111
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.
Pre-assignment Details  
Arm/Group Title 0 mg Memantine 20 mg Memantine 40 mg Memantine
Hide Arm/Group Description Participants who received placebo PO qd Participants randomized to 20 mg memantine PO qd Participants randomized to 40mg memantine PO qd
Period Title: Overall Study
Started 34 37 40
Completed 31 31 28
Not Completed 3 6 12
Arm/Group Title 0 mg Memantine 20 mg Memantine 40 mg Memantine Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 34 37 40 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 37 participants 40 participants 111 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
 100.0%
37
 100.0%
40
 100.0%
111
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 37 participants 40 participants 111 participants
29.1  (7.2) 32.4  (9.3) 31.3  (8.8) 31.0  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 37 participants 40 participants 111 participants
Female
11
  32.4%
12
  32.4%
13
  32.5%
36
  32.4%
Male
23
  67.6%
25
  67.6%
27
  67.5%
75
  67.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 37 participants 40 participants 111 participants
34 37 40 111
1.Primary Outcome
Title Number of Drinks Consumed on Day 7
Hide Description [Not Specified]
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0 mg Memantine 20 mg Memantine 40 mg Memantine
Hide Arm/Group Description:
Participants who received placebo
Participants randomized to 20 mg memantine
Participants randomized to 40mg memantine
Overall Number of Participants Analyzed 31 31 28
Mean (Standard Deviation)
Unit of Measure: standard drinks
5.84  (3.67) 5.61  (4.6) 6.21  (4.61)
2.Primary Outcome
Title Baseline-adjusted Craving (YCS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0 mg Memantine 20 mg Memantine 40 mg Memantine
Hide Arm/Group Description:
Participants who received placebo
Participants randomized to 20 mg memantine
Participants randomized to 40mg memantine
Overall Number of Participants Analyzed 31 31 28
Least Squares Mean (Standard Error)
Unit of Measure: millimeters
20.2  (2.16) 14.1  (2.23) 21.4  (2.23)
3.Secondary Outcome
Title Stimulation Responses to Alcohol
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all those who had complete data, which is less than those listed in the Participant Flow module
Arm/Group Title 0 mg Memantine 20 mg Memantine 40 mg Memantine
Hide Arm/Group Description:
Participants who received placebo
Participants randomized to 20 mg memantine
Participants randomized to 40mg memantine
Overall Number of Participants Analyzed 28 28 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.643  (4.923) 4.321  (5.313) 6.444  (6.536)
4.Secondary Outcome
Title Sedation Responses to Alcohol
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis includes all those who had complete data, which is less than those listed in the Participant Flow module
Arm/Group Title 0 mg Memantine 20 mg Memantine 40 mg Memantine
Hide Arm/Group Description:
Participants who received placebo
Participants randomized to 20 mg memantine
Participants randomized to 40mg memantine
Overall Number of Participants Analyzed 28 28 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.286  (5.381) 3.964  (6.327) 3.37  (5.085)
Time Frame Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0 mg 20 mg 40 mg
Hide Arm/Group Description Participants who received placebo Participants randomized to 20 mg memantine Participants randomized to 40mg memantine
All-Cause Mortality
0 mg 20 mg 40 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
0 mg 20 mg 40 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/37 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
0 mg 20 mg 40 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/34 (64.71%)   24/37 (64.86%)   31/40 (77.50%) 
Gastrointestinal disorders       
Abdominal Pain *  6/34 (17.65%)  2/37 (5.41%)  3/40 (7.50%) 
nausea *  9/34 (26.47%)  5/37 (13.51%)  10/40 (25.00%) 
vomit *  5/34 (14.71%)  2/37 (5.41%)  0/40 (0.00%) 
General disorders       
Headache *  9/34 (26.47%)  12/37 (32.43%)  16/40 (40.00%) 
fatigue *  6/34 (17.65%)  5/37 (13.51%)  9/40 (22.50%) 
Nervous system disorders       
Dizzy *  5/34 (14.71%)  3/37 (8.11%)  12/40 (30.00%) 
insomnia *  2/34 (5.88%)  4/37 (10.81%)  7/40 (17.50%) 
confusion *  3/34 (8.82%)  4/37 (10.81%)  8/40 (20.00%) 
Psychiatric disorders       
nervous *  3/34 (8.82%)  4/37 (10.81%)  0/40 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Suchitra Krishnan-Sarin, Associate Professor of Psychiatry
Organization: Yale University
Phone: 203-974-7595
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00630955     History of Changes
Other Study ID Numbers: 0602001068
P50AA012870 ( U.S. NIH Grant/Contract )
First Submitted: February 27, 2008
First Posted: March 7, 2008
Results First Submitted: August 19, 2013
Results First Posted: March 5, 2014
Last Update Posted: July 11, 2018