Status:
COMPLETED
Effectiveness of Memantine in Treating Cocaine-Dependent Individuals - 2
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Research Foundation for Mental Hygiene, Inc.
Conditions:
Cocaine-Related Disorders
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Cocaine is one of the most widely abused drugs in the United States. Memantine is a type of drug called an NMDA receptor antagonist. It works by decreasing normal excitement in the brain. NMDA recepto...
Detailed Description
Memantine is a non-competitive NMDA receptor antagonist that works by decreasing normal excitement in the brain. Dopamine plays a role in the rewarding and addictive properties of cocaine, however, pa...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for current cocaine dependence
- Use of cocaine at least four days in the month prior to enrollment or episodic cocaine binges of at least $200 worth at least twice each month (confirmed by urine toxicology test)
Exclusion
- Meets DSM-IV criteria for major depression, bipolar disorder, schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse
- History of seizures in the two years prior to enrollment
- History of seizures related to current substance abuse (including cocaine, alcohol, or benzodiazepine)
- History of an allergic reaction to memantine
- Chronic organic mental disorder
- Current significant suicidal risk, history of significant suicidal behavior, or any suicide attempt within the year prior to enrollment
- Pregnant or breastfeeding
- Failure to use adequate contraception
- Unstable physical disorders that might make participation hazardous, such as hypertension, acute hepatitis (individuals with chronic mildly elevated transaminase levels at 2 to 3 times the upper normal limit are not excluded if their PT/PTT is normal), renal impairment, or diabetes
- Current coronary vascular disease, or suspected by an abnormal ECG or history of cardiac symptoms
- Cardiac conduction system disease, as indicated by QRS duration greater than 0.11
- History of failure to respond to a previous trial with memantine
- Currently meets DSM-IV criteria for substance dependence or abuse disorder other than nicotine or marijuana
- Currently taking psychotropic medications, excluding zolpidem or trazodone for insomnia
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00134901
Start Date
March 1 2003
End Date
May 1 2007
Last Update
April 24 2019
Active Locations (1)
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1
Research Foundation for Mental Hygiene, Inc.
New York, New York, United States, 10032