A Placebo-Controlled Trial of Memantine for Alcohol Dependence

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ethanol; Memantine

Criteria

Inclusion Criteria:

1. Males or females between the ages of 18-65 yrs.

2. 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

3. 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.

4. Expresses desire to stop drinking alcohol.

5. Does not require any psychotropic medication.

6. Able to provide informed consent and comply with study procedures.

7. Signed informed consent.

Exclusion Criteria:

1. Dependence on opiates

2. Meets DSM-IV criteria for schizophrenia or bipolar Disorder. Has a psychotic illness or is at risk for suicidal behavior.

3. 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.

4. Currently taking psychotropic medication.

5. In need of inpatient alcohol detoxification.

6. Any renal disease or insufficiency.

7. Clinically significant and symptomatic medical disorder requiring active intervention

8. Female patients who are lactating or who have childbearing potential and who refuse to use birth control (hormone or barrier) or are pregnant.

9. Patients for whom treatment of alcoholism is being mandated by legal action.

10. Patients with active malignancy (other than non- melanoma skin cancer of carcinoma in situ of uterine cervix) within 5 years of beginning study.

11. Known or suspected hypersensitivity to memantine.

12. Intolerable adverse event during Single Blind Placebo Lead-in Phase.

13. Patients taking naltrexone or antabuse.