Memantine and Naltrexone Treatment for Opioid Dependence

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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 individuals.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Memantine; Naltrexone

Criteria

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