Phase 2
N=81
Memantine and Naltrexone Treatment for Opioid Dependence
Opioid Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00125515 ↗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
| Outcome | Result | p-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
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.