The number of new heroin users and problems associated with heroin use have increased steadily over the past several years. Currently, naltrexone is one of the drugs used to treat heroin dependence. The purpose of this study is to determine the effectiveness of another drug, memantine, as a supplement to naltrexone in treating heroin-dependent individuals.

Condition	Intervention	Phase
Heroin Dependence	Drug: Memantine	Phase II

Further Study Details: 

Primary Outcomes: Safety

Methadone maintenance is currently the most effective treatment for opioid dependence, but has limitations and is controversial. An alternative pharmacological strategy, naltrexone maintenance, currently has limited usefulness due to poor compliance and low patient acceptability. Preclinical studies and preliminary clinical observations support the use of NMDA receptor antagonists in treating opioid dependence. In humans, NMDA receptor antagonists reduce signs and symptoms associated with opiate withdrawl. In addition, NMDA receptor antagonists reduce subjective effects of heroin and heroin-craving. 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 165 heroin-dependent patients who completed detoxification. Participants will be randomly assigned to one of three conditions: - naltrexone + placebo, - naltrexone + memantine (15 mg bid), - naltrexone + 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. Repeated assessments will also be completed 1, 2, and 3 months following the end of treatment. Primary outcome measures will include retention in treatment at the end of the study and heroin abstinence in the final four weeks prior to the study endpoint.

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion:

• Meets DSM-IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine test for opiates, and a positive naloxone challenge test if the diagnosis is unclear

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

Study chairs or principal investigators

Adam Bisaga, M.D.,  Principal Investigator,  Columbia University   

Study ID Numbers:  NIDA-00429-1; K23-00429-1
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125515
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-02