Currently, naltrexone is one of the methods used to treat heroin dependence. However, treatment with naltrexone has been controversial due to poor compliance. The purpose of this study is to evaluate the effectiveness of memantine as a supplement to naltrexone in treating heroin-dependent individuals.

Condition	Intervention	Phase
Heroin Dependence	Drug: Memantine	Phase III

Further Study Details: 

Primary Outcomes: Safety; Heroin abstinence
Expected Total Enrollment:  200

Maintenance treatment with opioid agonists is the major pharmacological strategy that is currently available for the treatment of heroin dependence. However, this treatment approach remains controversial and has several limitations. Another pharmacological strategy, naltrexone maintenance, has limited usefulness due to poor compliance and low acceptability in patients seeking treatment. Therefore, alternative treatment approaches, including novel medications as well as pharmacological and behavioral augmentation strategies, are greatly needed to supplement naltrexone maintenance. The purpose of this study is to evaluate the efficacy of memantine as an adjunct to standard naltrexone treatment in heroin-dependent individuals.

This double-blind, 12-week trial will include 200 heroin-dependent individuals who have completed detoxification. Participants will be randomly assigned 1 of 3 conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and memantine (30 mg bid).

Memantine and matching placebo will be prepared and dispensed by the research pharmacy in New York State Psychiatric Institute. Compliance with memantine will be assessed monthly based on blood samples for serum memantine levels. Memantine or placebo will be taken at home, whereas naltrexone will be taken 3 times each week at the clinic. Naltrexone doses of 100 mg will be given on Mondays and Wednesdays, and doses of 150 mg will be given on Fridays. Study visits for all participants will occur 3 times each week during the 12-week trial. These visits will include urine toxicology tests, bloodwork, and research ratings (including safety measures and side effect assessments). In addition, twice each week participants will receive a psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. Participants will be re-evaluated at 1, 2, and 3 months following Week 12 of treatment.

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

Criteria

Inclusion Criteria:

• Meets DSM-IV criteria for opiate dependence disorder of at least 6 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 to use adequate contraceptive methods
• Active medical illness, such as untreated hypertension, acute hepatitis with SGOT or SGPT levels greater than 2 times normal, unstable diabetes, or organic mental disorder (e.g., AIDS dementia)
• Current diagnosis of a psychiatric disorder, 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 taking opiates for chronic pain or medical illness
• Currently participating in another intensive psychotherapy or substance abuse treatment program
• Currently taking psychotropic medications
• Currently participating in a methadone maintenance treatment program
• Regular use of illicit methadone, that is more than 30 mg per week
• History of accidental drug overdose within the 3 years prior to enrollment
• History of any drug overdose following detoxification, defined as an episode of opioid-induced unconsciousness or incapacitation

Please refer to this study by ClinicalTrials.gov identifier  NCT00126711

Adam Bisaga, M.D.      (212)543-6542    bisagaa@pi.cpmc.columbia.edu

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

Study chairs or principal investigators

Adam Bisaga, M.D.,  Principal Investigator,  New York State Psychiatric Institute   

Study ID Numbers:  NIDA-15822-1; R01-15822-1
Last Updated:  August 16, 2005
Record first received:  August 2, 2005
ClinicalTrials.gov Identifier:  NCT00126711
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23