NCT00246415

Brief Summary

The purpose of this study is to obtain a preliminary indication of the safety and effectiveness of oral memantine (40 mg/day) in alcohol dependent patients. This study is a 16-week study comparison of memantine and placebo in patients with alcohol dependence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

October 8, 2008

Status Verified

October 1, 2008

Enrollment Period

3.1 years

First QC Date

October 27, 2005

Last Update Submit

October 7, 2008

Conditions

Alcohol Dependence (Primary Condition)Alcohol Abuse

Keywords

Alcohol DependenceAlcohol AbuseMemantineAlcohol Treatment

Outcome Measures

Primary Outcomes (2)

  • Alcohol consumption- Standard Drink Units (Time line Followback)

  • Abstinence from alcohol (Time line Followback)

Secondary Outcomes (1)

  • Clinical Global Impression-Alcohol

Interventions

MemantineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females between the ages of 18-65 yrs.
  • Meets DSM-IV criteria for current alcohol dependence. Volunteers may meet criteria for other substance abuse, or dependence on other drugs (nicotine, marijuana or cocaine) as long as the dependence on marijuana or cocaine is secondary to alcohol dependence
  • Medically healthy on the basis of physical examination and medical history, vital signs, ECG and laboratory tests, with a negative blood pregnancy test for females.
  • Expresses desire to stop drinking alcohol.
  • Does not require any psychotropic medication.
  • Able to provide informed consent and comply with study procedures.
  • Signed informed consent.

You may not qualify if:

  • Dependence on opiates
  • Meets DSM-IV criteria for schizophrenia or bipolar Disorder. Has a psychotic illness or is at risk for suicidal behavior.
  • History of delerium tremens (hallucinations, psychosis, agitation) secondary to alcohol withdrawal, a personal or family history of seizure disorder, a personal history of moderate/severe head trauma.
  • Currently taking psychotropic medication.
  • In need of inpatient alcohol detoxification.
  • Any renal disease or insufficiency.
  • Clinically significant and symptomatic medical disorder requiring active intervention
  • Female patients who are lactating or who have childbearing potential and who refuse to use birth control (hormone or barrier) or are pregnant.
  • Patients for whom treatment of alcoholism is being mandated by legal action.
  • Patients with active malignancy (other than non- melanoma skin cancer of carcinoma in situ of uterine cervix) within 5 years of beginning study.
  • Known or suspected hypersensitivity to memantine.
  • Intolerable adverse event during Single Blind Placebo Lead-in Phase.
  • Patients taking naltrexone or antabuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • Risnes LF, Eggesbo LM, Zuhlke S, Dahal-Koirala S, Neumann RS, Lundin KEA, Christophersen A, Sollid LM. Circulating CD103+ gammadelta and CD8+ T cells are clonally shared with tissue-resident intraepithelial lymphocytes in celiac disease. Mucosal Immunol. 2021 Jul;14(4):842-851. doi: 10.1038/s41385-021-00385-8. Epub 2021 Mar 2.

    PMID: 33654213DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Memantine

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Suzette M. Evans, PhD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 31, 2005

Study Start

November 1, 2002

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

October 8, 2008

Record last verified: 2008-10

Locations

US(1)