Effectiveness of Memantine in Treating Cocaine-Dependent Individuals - 2
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Intervention: Memantine; placebo
Intervention description: Memantine; placebo
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Cocaine dependence; treatment; memantine

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.
    

Eligibility 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