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Completed

NCT Number: NCT00125515

Memantine and Naltrexone Treatment for Opioid Dependence

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Memantine

Drug

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

Naltrexone

Drug

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

Primary outcomes

  1. Retention in Treatment

    Time frame: Number of participants who complete 12 weeks of treatment

    The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Evaluation of NMDA Antagonist for Opiate Dependence

Acronym: NAMHS-1

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 1, 2005
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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