Family History Study of Alcohol Consumption Using Memantine

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00630955
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 111
• Location: 1
• Arms: 3
• Duration (Months): 62
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking	Drug: memantine; Drug: Memantine; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• Official Title: NMDA Antagonist Efficacy in Reducing Human Alcohol Consumption: Impact of Family History
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 20 mg memantine	Drug: memantine; Memantine 20 mg once per day for 7 days; Other Names: Namenda
Experimental: 2 40 mg memantine	Drug: Memantine; Memantine 40 mg once per day for 7 days; Other Names: Namenda
Placebo Comparator: 3	Drug: Placebo; Placebo once per day for 7 days

Outcome Measures

Primary Outcome Measures

1. Number of Drinks Consumed on Day 7 [Day 7]

2. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMHC	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Suchitra Krishnan-Sarin, Ph.D., Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00630955
• Other Study ID Numbers: 0602001068; P50AA012870
• First Posted: Mar 7, 2008
• Last Update Posted: Mar 17, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Yale University: Alcohol Drinking; Memantine
• Additional relevant MeSH terms: Alcohol Drinking; Memantine

Study Results

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.

Arm/Group Title	0 mg Memantine	20 mg Memantine	40 mg Memantine
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

Baseline Characteristics

Arm/Group Title	0 mg Memantine	20 mg Memantine	40 mg Memantine	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	34	37	40	111
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	34 100%	37 100%	40 100%	111 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.1 (7.2)	32.4 (9.3)	31.3 (8.8)	31.0 (8.6)
Sex: Female, Male (Count of 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 (participants) [Number]
United States	34 100%	37 100%	40 100%	111 100%

Outcome Measures

1. Primary Outcome

Title	Number of Drinks Consumed on Day 7
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0 mg Memantine	20 mg Memantine	40 mg Memantine
Arm/Group Description	Participants who received placebo	Participants randomized to 20 mg memantine	Participants randomized to 40mg memantine
Measure Participants	31	31	28
Mean (Standard Deviation) [standard drinks]	5.84 (3.67)	5.61 (4.6)	6.21 (4.61)

2. Primary Outcome

Title	Baseline-adjusted Craving (YCS)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0 mg Memantine	20 mg Memantine	40 mg Memantine
Arm/Group Description	Participants who received placebo	Participants randomized to 20 mg memantine	Participants randomized to 40mg memantine
Measure Participants	31	31	28
Least Squares Mean (Standard Error) [millimeters]	20.2 (2.16)	14.1 (2.23)	21.4 (2.23)

3. Secondary Outcome

Title	Stimulation Responses to Alcohol
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

Outcome Measure Data

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
Arm/Group Description	Participants who received placebo	Participants randomized to 20 mg memantine	Participants randomized to 40mg memantine
Measure Participants	28	28	27
Mean (Standard Deviation) [units on a scale]	4.643 (4.923)	4.321 (5.313)	6.444 (6.536)

4. Secondary Outcome

Title	Sedation Responses to Alcohol
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

Outcome Measure Data

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
Arm/Group Description	Participants who received placebo	Participants randomized to 20 mg memantine	Participants randomized to 40mg memantine
Measure Participants	28	28	27
Mean (Standard Deviation) [units on a scale]	3.286 (5.381)	3.964 (6.327)	3.37 (5.085)

Adverse Events

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
Arm/Group Title	0 mg		20 mg		40 mg
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	0 mg		20 mg		40 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/37 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	0 mg		20 mg		40 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/34 (64.7%)		24/37 (64.9%)		31/40 (77.5%)
Gastrointestinal disorders
Abdominal Pain	6/34 (17.6%)		2/37 (5.4%)		3/40 (7.5%)
nausea	9/34 (26.5%)		5/37 (13.5%)		10/40 (25%)
vomit	5/34 (14.7%)		2/37 (5.4%)		0/40 (0%)
General disorders
Headache	9/34 (26.5%)		12/37 (32.4%)		16/40 (40%)
fatigue	6/34 (17.6%)		5/37 (13.5%)		9/40 (22.5%)
Nervous system disorders
Dizzy	5/34 (14.7%)		3/37 (8.1%)		12/40 (30%)
insomnia	2/34 (5.9%)		4/37 (10.8%)		7/40 (17.5%)
confusion	3/34 (8.8%)		4/37 (10.8%)		8/40 (20%)
Psychiatric disorders
nervous	3/34 (8.8%)		4/37 (10.8%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.