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Memantine as a Supplement to Naltrexone in Treating Heroin Dependence (NAMHS)

Primary Purpose

Opioid Dependence, Heroin Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vivitrol
memantine
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 abuse, opiate abuse, opioid dependence, naltrexone, memantine

Eligibility Criteria

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

Inclusion Criteria:

  1. Adult, aged 18-60.
  2. Meets Diagnostic and Statistical Manual IV (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.
  3. Able to give informed consent.

Exclusion Criteria:

  1. Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
  2. Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with serum glutamic oxaloacetic transaminase or serum glutamic-pyruvic transaminase levels >2 times normal, unstable diabetes, chronic organic mental disorder (e.g., AIDS dementia).
  3. Active psychiatric disorder which 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.
  4. History of allergic reaction to buprenorphine, naloxone, memantine, naltrexone, clonidine, or clonazepam.
  5. Currently prescribed or regularly taking opiates for chronic pain or medical illness.
  6. Current participation in another intensive psychotherapy or substance abuse treatment program or currently prescribed psychotropic medications.
  7. Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone (>30 mg per week).
  8. History of accidental drug overdose in the last three 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

  • STARS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Memantine and Vivitrol

Placebo and Vivitrol

Arm Description

intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)

intramuscular injection of Vivitrol 380 mg and Placebo

Outcomes

Primary Outcome Measures

Opiate Use Measured by Urine Toxicology Results
Opiate use was qualified by the number of opiate positive urine results.
Retention in Treatment The Primary Outcome Measure Will be the Dichotomous Measure Retention in Treatment (Whether the Patient Completes the 12 Week Trial, Yes/no).

Secondary Outcome Measures

Opiate Craving Based on Heroin Craving Scale
Range 0- 100 ( 0= no craving; 100= very strong craving

Full Information

First Posted
May 17, 2007
Last Updated
June 19, 2018
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00476242
Brief Title
Memantine as a Supplement to Naltrexone in Treating Heroin Dependence
Acronym
NAMHS
Official Title
Placebo Controlled Study of Memantine as an Adjunct to Naltrexone in the Treatment of Opioid Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (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
No

5. Study Description

Brief Summary
Prospective participants will undergo a screening process at the clinic to determine eligibility. After screening, eligible patients will complete an 8-day inpatient detoxification, followed by a 12-week outpatient phase. Patients will be randomly assigned to one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid. Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month (the total of three injections) while memantine or placebo will be taken daily. In addition, patients will receive twice weekly psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The outpatient treatment will also consist of 3 weekly visits to the clinic in which patients will receive counseling to help maintain abstinence and improve compliance with study medication.
Detailed Description
In the proposed trial heroin-dependent patients undergoing detoxification will be randomly assigned to one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid. Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month (the total of three injections) while memantine or placebo will be taken daily. In addition, patients will receive twice weekly psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The goal of psychosocial intervention is to improve compliance with medication and maintain abstinence. A double-blind trial will last twelve weeks with assessments at baseline and at each appointment three times per week. After the completion of a double-blind study (experimental phase), participants will continue open label treatment with Vivitrol and therapy for additional three months (study extension phase). Repeated assessments will also be completed one, two, and three months following the end of double-blind treatment. For the experimental phase of the study, the primary aim is to test the efficacy of memantine in reducing early attrition and improving outcome in opioid-dependent individuals maintained on naltrexone and primary outcome measures will be retention in treatment by the end of the study and heroin abstinence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence, Heroin Dependence
Keywords
heroin abuse, opiate abuse, opioid dependence, naltrexone, memantine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memantine and Vivitrol
Arm Type
Experimental
Arm Description
intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)
Arm Title
Placebo and Vivitrol
Arm Type
Placebo Comparator
Arm Description
intramuscular injection of Vivitrol 380 mg and Placebo
Intervention Type
Drug
Intervention Name(s)
Vivitrol
Other Intervention Name(s)
intramuscular injection of Vivitrol 380 mg
Intervention Description
intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
Intervention Type
Drug
Intervention Name(s)
memantine
Intervention Description
Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment.
Primary Outcome Measure Information:
Title
Opiate Use Measured by Urine Toxicology Results
Description
Opiate use was qualified by the number of opiate positive urine results.
Time Frame
3x/week during 12 weeks of the trial or study participation
Title
Retention in Treatment The Primary Outcome Measure Will be the Dichotomous Measure Retention in Treatment (Whether the Patient Completes the 12 Week Trial, Yes/no).
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Opiate Craving Based on Heroin Craving Scale
Description
Range 0- 100 ( 0= no craving; 100= very strong craving
Time Frame
Average of twice weekly assessments for 12 weeks of study or length of participation

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 Criteria: Adult, aged 18-60. Meets Diagnostic and Statistical Manual IV (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 Criteria: Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods. Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with serum glutamic oxaloacetic transaminase or serum glutamic-pyruvic transaminase levels >2 times normal, unstable diabetes, chronic organic mental disorder (e.g., AIDS dementia). Active psychiatric disorder which 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 three 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, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
STARS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21715107
Citation
Bisaga A, Sullivan MA, Cheng WY, Carpenter KM, Mariani JJ, Levin FR, Raby WN, Nunes EV. A placebo controlled trial of memantine as an adjunct to oral naltrexone for opioid dependence. Drug Alcohol Depend. 2011 Dec 1;119(1-2):e23-9. doi: 10.1016/j.drugalcdep.2011.05.019. Epub 2011 Jun 28.
Results Reference
result
Links:
URL
http://www.stars.columbia.edu
Description
stars website

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Memantine as a Supplement to Naltrexone in Treating Heroin Dependence

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