Status:
COMPLETED
Memantine and Naltrexone Treatment for Opioid Dependence
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified heroin-dependent indivi...
Detailed Description
The primary aim of this study is to test the efficacy of memantine, a noncompetitive NMDA receptor antagonist, in reducing early attrition and improving outcome in opioid-dependent individuals maintai...
Eligibility Criteria
Inclusion
- Inclusion:
- Adult, aged 18-60.
- Meets DSM-IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
- Able to give informed consent.
- Exclusion:
- Pregnancy or breastfeeding
- Failure in a sexually active woman to use adequate contraceptive methods
- Active medical illness that might make participation hazardous, such as untreated hypertension, acute hepatitis with SGOT or SGPT levels \> 2 times normal, unstable diabetes, or chronic organic mental disorder (e.g., AIDS dementia)
- Active psychiatric disorder that might interfere with participation or make participation hazardous, including DSM-IV schizophrenia, bipolar disorder with mania or psychosis, and depressive disorder with suicide risk or 1 or more suicide attempts within the past year.
- History of allergic reaction to buprenorphine, naloxone, memantine, naltrexone, clonidine, or clonazepam
- Currently prescribed or regularly taking opiates for chronic pain or medical illness
- Current participation in another intensive psychotherapy or substance abuse treatment program or currently prescribed psychotropic medications
- Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone ( \> 30 mg per week)
- History of accidental drug overdose in the last 3 years or any other significant history of overdose following detoxification, defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00125515
Start Date
June 1 2005
End Date
August 1 2008
Last Update
June 18 2018
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032