Effectiveness of Memantine in Treating Cocaine-Dependent Individuals - 2

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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 receptor antagonists have shown to reduce cocaine-induced dopamine release in animal models, as well as lessen conditioned cocaine cues. The purpose of this study is to determine the effectiveness of memantine in preventing relapse to cocaine use in cocaine dependent individuals. In addition, this study will determine whether memantine produces better results than a placebo in decreasing cocaine craving, psychological symptoms, functional impairment, and discontinuation of treatment in cocaine dependent individuals.

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

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute on Drug Abuse (NIDA); Research Foundation for Mental Hygiene, Inc.
• Treatments: Cocaine; Memantine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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