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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00125515
First received: July 28, 2005
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Opioid Dependence
Drug: Memantine
Drug: Naltrexone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of NMDA Antagonist for Opiate Dependence

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Retention in Treatment [ Time Frame: Number of participants who complete 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.


Enrollment: 81
Study Start Date: June 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo plus oral naltrexone
Drug: Naltrexone
Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.
Other Name: Naltrexone
Active Comparator: Memantine 30 mg bid
Memantine 30 mg bid plus oral naltrexone
Drug: Memantine
One arm receives 30 mg bid and the other arm receives receives 15mg bid
Other Name: Memantine
Drug: Naltrexone
Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.
Other Name: Naltrexone
Active Comparator: Memantine 15 mg bid
memantine 15 mg bid plus oral naltrexone
Drug: Memantine
One arm receives 30 mg bid and the other arm receives receives 15mg bid
Other Name: Memantine
Drug: Naltrexone
Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.
Other Name: Naltrexone

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125515

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Adam Bisaga, M.D. Columbia University
  More Information

Additional Information:
No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00125515     History of Changes
Other Study ID Numbers: #4847/R01-15822, K23DA000429
Study First Received: July 28, 2005
Results First Received: December 18, 2012
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
Heroin
Opiates
naltrexone
memantine

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Memantine
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on September 18, 2014