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Phase 2 N=81 Randomized Triple-blind Treatment

Memantine and Naltrexone Treatment for Opioid Dependence

Opioid Dependence

Enrolled (actual)
81
Serious AEs
1.2%
Results posted
Jan 2013
Primary outcome: Primary: Retention in Treatment — 7; 5; 6 participants — p=0.32

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Memantine (Drug); Naltrexone (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
New York State Psychiatric Institute
Primary completion
Aug 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Retention in Treatment
7; 5; 6 0.32

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00125515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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