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Effectiveness of Memantine in Treating Cocaine-Dependent Individuals - 2

Primary Purpose

Cocaine-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Memantine
placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring Cocaine dependence, treatment, memantine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Foundation for Mental Hygiene, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Memantine

Placebo

Arm Description

Memantine

Placebo

Outcomes

Primary Outcome Measures

Weekly Cocaine Use
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
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;

Full Information

First Posted
August 23, 2005
Last Updated
April 22, 2019
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA), Research Foundation for Mental Hygiene, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00134901
Brief Title
Effectiveness of Memantine in Treating Cocaine-Dependent Individuals - 2
Official Title
A Double-Blind, Placebo-Controlled Trial of the Effectiveness of Memantine in Treating Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA), Research Foundation for Mental Hygiene, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
Cocaine dependence, treatment, memantine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memantine
Arm Type
Experimental
Arm Description
Memantine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Memantine 40mg/day
Intervention Description
Memantine
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Weekly Cocaine Use
Description
Mean number of cocaine using days per week based on self reported use verified by cocaine toxicology results.
Time Frame
weekly use during length of study participation
Secondary Outcome Measure Information:
Title
Cocaine Abstinence Based on Daily Self Reported Cocaine Use
Description
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;
Time Frame
reported weekly cocaine use for 12 weeks/ or study participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances R Levin, M.D.
Organizational Affiliation
Research Foundation for Mental Hygiene, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Foundation for Mental Hygiene, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stars.columbia.edu
Description
Substance Treatment and Abuse Research Service (STARS)

Learn more about this trial

Effectiveness of Memantine in Treating Cocaine-Dependent Individuals - 2

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