Effectiveness of Memantine in Treating Cocaine-Dependent Individuals - 2

NCT00134901 | Completed Phase 2 Results DMC

• 2 other identifiers: #4496-NIDA-12761-2P50DA012761
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine-Related Disorders

Keywords

Cocaine dependence; treatment; memantine

Outcome Measures

Primary Outcomes (1)

• Weekly Cocaine Use

  Mean number of cocaine using days per week based on self reported use verified by cocaine toxicology results.

  weekly use during length of study participation

Secondary Outcomes (1)

• Cocaine Abstinence Based on Daily Self Reported Cocaine Use

  reported weekly cocaine use for 12 weeks/ or study participation

Study Arms (2)

Memantine

EXPERIMENTAL

Memantine

Drug: Memantine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

Memantine DRUG

Memantine

Also known as: Memantine 40mg/day

Memantine

placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Research Foundation for Mental Hygiene, Inc.: collaborator

Study Sites (1)

Research Foundation for Mental Hygiene, Inc.

New York, New York, 10032, United States

Location

Related Links

• Substance Treatment and Abuse Research Service (STARS)

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Memantine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

participants who had achieved abstinence during the lead-in remained abstinent throughout the trial and there was little relapse-like behavior for a medication to address.

Results Point of Contact

• Title: Dr Adam Bisaga
• Organization: New York State Psychiatric Institute

bisagaa@nyspi.columbia.edu

(646) 774-6155

Study Officials

• Frances R Levin, M.D.

  Research Foundation for Mental Hygiene, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Substance Use Disorder

Study Record Dates

• First Submitted: August 23, 2005
• First Posted: August 25, 2005
• Study Start: March 1, 2003
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: April 24, 2019
• Results First Posted: September 5, 2014

Record last verified: 2019-04

Locations

US (1)