Effectiveness of Memantine in Treating Cocaine-Dependent Individuals - 2
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

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.
    

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, past clinical studies have not been successful in using dopamine agonists
      in treating cocaine dependent individuals. Non-competitive NMDA receptor antagonists have
      shown to reduce cocaine-induced dopamine release in animal models and lessen conditioned
      cocaine cues. This study will evaluate memantine in treating cocaine dependent individuals
      and its ability to prevent relapse to cocaine use. Specifically, the aim of this study is to
      determine if memantine is superior to placebo in decreasing cocaine craving, psychological
      symptoms, functional impairment, and discontinuation of treatment for cocaine abuse.

      Participants will enter a 2-week, single-blind, placebo lead-in phase, during which they will
      visit the clinic three times each week. At each study visit, urine samples and other rating
      assessments will be collected. In addition, participants will attend weekly therapy sessions.
      In order to continue in the trial, participants are required to attend at least four out of
      the first six study visits and both therapy sessions. Eligible participants will then be
      randomly assigned to receive either memantine or placebo for the duration of the 12-week,
      double-blind phase of the trial. Study visits will continue to occur three times each week;
      participants will also receive weekly therapy. Memantine will be taken twice each day.
      Participants who complete the 12-week trial will enter a 2-week lead-out phase, during which
      they will be tapered back to a placebo in a single-blind manner. Weekly psychotherapy
      sessions will continue until the end of Week 14.
    

Intervention name(s): Memantine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Memantine; placebo
Other intervention name(s): Memantine 40mg/day
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine dependence; treatment; memantine