deltatrials
Completed PHASE2 INTERVENTIONAL 3-arm NCT00125515

Memantine and Naltrexone Treatment for Opioid Dependence (NAMHS-1)

Evaluation of NMDA Antagonist for Opiate Dependence

Sponsor: National Institute on Drug Abuse (NIDA)

Updated 11 times since 2017 Last updated: May 17, 2018 Started: Jun 30, 2005 Primary completion: Aug 31, 2008 Completion: Aug 31, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Opioid Dependence, this trial is completed. The trial is conducted by National Institute on Drug Abuse (NIDA) and has accumulated 11 data snapshots since 2005. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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 heroin-dependent patients who completed detoxification. Participants will be randomly assigned to one of three conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and 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.

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 heroin-dependent patients who completed detoxification. Participants will be randomly assigned to one of three conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and 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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotCompleted~Jul 2018 – ~Jan 2021 · 30 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Dec 2022 · 12 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

Show 6 earlier versions
  1. Dec 2021 — Dec 2022 [monthly]

    Completed PHASE2

  2. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE2

  3. Jul 2018 — Jan 2021 [monthly]

    Completed PHASE2

  4. Jun 2018 — Jul 2018 [monthly]

    Completed PHASE2

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

  6. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Jun 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute on Drug Abuse (NIDA)
  • New York State Psychiatric Institute
Data source: New York State Psychiatric Institute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations