CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Memantine +1 moredrug
Likely dose
Memantine 15-30 mg twice daily OR Naltrexone 50 mg daily (100 mg Monday/Wednesday, 150 mg Friday)AI-extracted
Key inclusion· 3
  • ✓Age 18-60 years
  • ✓Meets DSM-IV criteria for current opioid dependence disorder lasting at least 6 months, confirmed by positive urine opioid test and positive naloxone challenge test if diagnosis unclear
  • ✓Able to give informed consent
Key exclusion· 8
  • ✕Pregnancy or breastfeeding
  • ✕Active medical illness that may be hazardous, including untreated hypertension, acute hepatitis with SGOT or SGPT >2× normal, unstable diabetes, or chronic organic mental disorder (e.g., AIDS dementia)
  • ✕Active psychiatric disorder that may interfere with or make participation hazardous: schizophrenia, bipolar disorder with mania or psychosis, or depressive disorder with suicide risk or ≥1 suicide attempt in past year
  • ✕History of allergic reaction to buprenorphine, naloxone, memantine, naltrexone, clonidine, or clonazepam

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00125515
NCT00125515Phase 2Completed
CompareCT.gov

Evaluation of NMDA Antagonist for Opiate Dependence

New York State Psychiatric Institute·interventional·Posted Aug 1, 2005·Updated Jun 18, 2018

In Brief

A Phase 2 clinical trial evaluating Memantine and Naltrexone for Opioid Dependence. Completed, enrolled 81 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 1, 2005
Enrollment StartJun 1, 2005
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 20.9 years ago

Interventions

Memantinedrug

One arm receives 30 mg bid and the other arm receives receives 15mg bid

Naltrexonedrug

Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.