Trial Outcomes & Findings for Family History Study of Alcohol Consumption Using Memantine (NCT NCT00630955)
NCT ID: NCT00630955
Last Updated: 2020-03-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
Day 7
Results posted on
2020-03-17
Participant Flow
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.
Participant milestones
| Measure |
0 mg Memantine
Participants who received placebo PO qd
|
20 mg Memantine
Participants randomized to 20 mg memantine PO qd
|
40 mg Memantine
Participants randomized to 40mg memantine PO qd
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
37
|
40
|
|
Overall Study
COMPLETED
|
31
|
31
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Family History Study of Alcohol Consumption Using Memantine
Baseline characteristics by cohort
| Measure |
0 mg Memantine
n=34 Participants
|
20 mg Memantine
n=37 Participants
|
40 mg Memantine
n=40 Participants
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
111 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
29.1 years
STANDARD_DEVIATION 7.2 • n=93 Participants
|
32.4 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
31.3 years
STANDARD_DEVIATION 8.8 • n=27 Participants
|
31.0 years
STANDARD_DEVIATION 8.6 • n=483 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
75 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=93 Participants
|
37 participants
n=4 Participants
|
40 participants
n=27 Participants
|
111 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 7Outcome measures
| Measure |
0 mg Memantine
n=31 Participants
Participants who received placebo
|
20 mg Memantine
n=31 Participants
Participants randomized to 20 mg memantine
|
40 mg Memantine
n=28 Participants
Participants randomized to 40mg memantine
|
|---|---|---|---|
|
Number of Drinks Consumed on Day 7
|
5.84 standard drinks
Standard Deviation 3.67
|
5.61 standard drinks
Standard Deviation 4.6
|
6.21 standard drinks
Standard Deviation 4.61
|
PRIMARY outcome
Timeframe: Day 7Craving 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.
Outcome measures
| Measure |
0 mg Memantine
n=31 Participants
Participants who received placebo
|
20 mg Memantine
n=31 Participants
Participants randomized to 20 mg memantine
|
40 mg Memantine
n=28 Participants
Participants randomized to 40mg memantine
|
|---|---|---|---|
|
Baseline-adjusted Craving (YCS)
|
20.2 millimeters
Standard Error 2.16
|
14.1 millimeters
Standard Error 2.23
|
21.4 millimeters
Standard Error 2.23
|
SECONDARY outcome
Timeframe: Day 7Population: Analysis includes all those who had complete data, which is less than those listed in the Participant Flow module
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.
Outcome measures
| Measure |
0 mg Memantine
n=28 Participants
Participants who received placebo
|
20 mg Memantine
n=28 Participants
Participants randomized to 20 mg memantine
|
40 mg Memantine
n=27 Participants
Participants randomized to 40mg memantine
|
|---|---|---|---|
|
Stimulation Responses to Alcohol
|
4.643 units on a scale
Standard Deviation 4.923
|
4.321 units on a scale
Standard Deviation 5.313
|
6.444 units on a scale
Standard Deviation 6.536
|
SECONDARY outcome
Timeframe: Day 7Population: Analysis includes all those who had complete data, which is less than those listed in the Participant Flow module
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.
Outcome measures
| Measure |
0 mg Memantine
n=28 Participants
Participants who received placebo
|
20 mg Memantine
n=28 Participants
Participants randomized to 20 mg memantine
|
40 mg Memantine
n=27 Participants
Participants randomized to 40mg memantine
|
|---|---|---|---|
|
Sedation Responses to Alcohol
|
3.286 units on a scale
Standard Deviation 5.381
|
3.964 units on a scale
Standard Deviation 6.327
|
3.37 units on a scale
Standard Deviation 5.085
|
Adverse Events
0 mg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
20 mg
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
40 mg
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0 mg
n=34 participants at risk
Participants who received placebo
|
20 mg
n=37 participants at risk
Participants randomized to 20 mg memantine
|
40 mg
n=40 participants at risk
Participants randomized to 40mg memantine
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
17.6%
6/34 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
5.4%
2/37 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
7.5%
3/40 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
|
Gastrointestinal disorders
nausea
|
26.5%
9/34 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
13.5%
5/37 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
25.0%
10/40 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
|
Gastrointestinal disorders
vomit
|
14.7%
5/34 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
5.4%
2/37 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
0.00%
0/40 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
|
General disorders
Headache
|
26.5%
9/34 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
32.4%
12/37 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
40.0%
16/40 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
|
Nervous system disorders
Dizzy
|
14.7%
5/34 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
8.1%
3/37 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
30.0%
12/40 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
|
General disorders
fatigue
|
17.6%
6/34 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
13.5%
5/37 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
22.5%
9/40 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
|
Psychiatric disorders
nervous
|
8.8%
3/34 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
10.8%
4/37 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
0.00%
0/40 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
|
Nervous system disorders
insomnia
|
5.9%
2/34 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
10.8%
4/37 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
17.5%
7/40 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
|
Nervous system disorders
confusion
|
8.8%
3/34 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
10.8%
4/37 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
20.0%
8/40 • Adverse event data was collected at baseline and during the 7 days of medication, as well as at the one week follow up
|
Additional Information
Dr. Suchitra Krishnan-Sarin, Associate Professor of Psychiatry
Yale University
Phone: 203-974-7595
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place