search
Back to results

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

Primary Purpose

Opioid Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Memantine
Naltrexone
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Dependence focused on measuring Heroin, Opiates, naltrexone, memantine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Memantine 30 mg bid

Memantine 15 mg bid

Arm Description

Placebo plus oral naltrexone

Memantine 30 mg bid plus oral naltrexone

memantine 15 mg bid plus oral naltrexone

Outcomes

Primary Outcome Measures

Retention in 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.

Secondary Outcome Measures

Full Information

First Posted
July 28, 2005
Last Updated
May 17, 2018
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00125515
Brief Title
Memantine and Naltrexone Treatment for Opioid Dependence
Acronym
NAMHS-1
Official Title
Evaluation of NMDA Antagonist for Opiate Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
Keywords
Heroin, Opiates, naltrexone, memantine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo plus oral naltrexone
Arm Title
Memantine 30 mg bid
Arm Type
Active Comparator
Arm Description
Memantine 30 mg bid plus oral naltrexone
Arm Title
Memantine 15 mg bid
Arm Type
Active Comparator
Arm Description
memantine 15 mg bid plus oral naltrexone
Intervention Type
Drug
Intervention Name(s)
Memantine
Intervention Description
One arm receives 30 mg bid and the other arm receives receives 15mg bid
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.
Primary Outcome Measure Information:
Title
Retention in Treatment
Description
The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.
Time Frame
Number of participants who complete 12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Bisaga, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Links:
URL
http://stars.columbia.edu
Description
stars website

Learn more about this trial

Memantine and Naltrexone Treatment for Opioid Dependence

We'll reach out to this number within 24 hrs