Effectiveness of Memantine in Treating Cocaine-Dependent Individuals - 2

This study has been completed.
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00134901
First received: August 23, 2005
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Cocaine-Related Disorders
Drug: Memantine
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Trial of the Effectiveness of Memantine in Treating Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Weekly Cocaine Use [ Time Frame: weekly use during length of study participation ] [ Designated as safety issue: No ]
    Mean number of cocaine using days per week based on self reported use verified by cocaine toxicology results.


Secondary Outcome Measures:
  • Cocaine Abstinence Based on Daily Self Reported Cocaine Use [ Time Frame: reported weekly cocaine use for 12 weeks/ or study participation ] [ Designated as safety issue: No ]
    A binary indicator of sustained abstinence, defined as three consecutive weeks of no cocaine use, obtained by self-report and verified using negative urine toxicology results, at any point of the trial;


Enrollment: 81
Study Start Date: March 2003
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memantine
Memantine
Drug: Memantine
Memantine
Other Name: Memantine 40mg/day
Placebo Comparator: Placebo
Placebo
Drug: placebo
placebo
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134901

Locations
United States, New York
Research Foundation for Mental Hygiene, Inc.
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Research Foundation for Mental Hygiene, Inc.
Investigators
Principal Investigator: Frances R Levin, M.D. Research Foundation for Mental Hygiene, Inc.
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00134901     History of Changes
Other Study ID Numbers: #4496-NIDA-12761-2, P50DA012761
Study First Received: August 23, 2005
Results First Received: August 25, 2014
Last Updated: August 25, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Memantine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014