Memantine and Naltrexone Treatment for Opioid Dependence

Condition(s) targeted: Opioid Dependence

Intervention: Memantine (Drug); Naltrexone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: New York State Psychiatric Institute

Official(s) and/or principal investigator(s):
Adam Bisaga, M.D., Principal Investigator, Affiliation: Columbia University

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.

Official title: Evaluation of NMDA Antagonist for Opiate Dependence

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Retention in Treatment

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 maintained on naltrexone. This double-blind, 12-week trial will include heroin-dependent patients who completed detoxification. Participants will be randomly assigned to one of three conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and memantine (30 mg bid). Naltrexone will be taken 3 times each week at the clinic, while memantine or placebo will be taken at home. In addition, twice each week patients will receive a psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The goal of the psychosocial intervention is to improve compliance with medication and maintain abstinence. Baseline assessments will be taken and compared to those completed at study visits, which will occur 3 times each week.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

New York State Psychiatric Institute, New York, New York 10032, United States

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Starting date: June 2005
Last updated: January 28, 2013