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Psychopharmacotherapy in Multiple Substances Abuse (MM opioid)

Primary Purpose

Substance Abuse

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Memantine
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female patient aged ≧18 and ≦65 years.
  2. A diagnosis of opioid abuse/dependence according to DSM-IV criteria made by a specialist in psychiatry.
  3. A diagnosis of multiple drug abuse/dependence according to DSM-IV criteria made by a specialist in psychiatry.
  4. Signed informed consent by patient or legal representative
  5. Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.

Exclusion Criteria:

  1. Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study.
  2. Females who are pregnant or nursing.
  3. Patients were diagnosed as other mental illness according to DMS-IV, except Major Depressive Disorder
  4. Patient has received dextromethorphan, or other selective cyclo- oxygenase 2 (Cox-2) inhibitors, or other anti-inflammatory medication within 1 week prior to first dose of double-blind medication.
  5. Current evidence of an uncontrolled and/or clinically significant medical condition (e.g., cardiac, hepatic and renal failure), which in the judgments of the investigator, would compromise patient safety or preclude study participation.
  6. History of intolerance to valproate or memantine or other Cox-2 inhibitors.
  7. History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by memantine.
  8. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to first dose of doubleblind medication.
  9. Diagnosis of or treatment for esophageal, gastric, pyloric channel, or duodenal ulceration or related complications (bleeding and/or perforation) within 30 days prior to receiving first dose of double-blind medication.
  10. Inclusion in another study of opioid dependence or study for another indication with psychotropic's within the last 30 days prior to start of study.
  11. Increase in total SGOT, SGPT, BUN and creatinine by more than 3X ULN (upper limit of normal).
  12. History of idiopathic or drug-induced agranulocytosis.
  13. Substance-related disorders within 6 months prior to study start, borderline personality disorder, schizophrenia, or other major psychiatric disorders as defined by DSM-IV criteria.

Sites / Locations

  • Ru-Band Lu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Memantine

Arm Description

Outcomes

Primary Outcome Measures

Urinary examination
Using urinary examination is aimed to test whether the patient is using substance or not.
Urinary examination
Using urinary examination is aimed to test whether the patient is using substance or not.
Urinary examination
Using urinary examination is aimed to test whether the patient is using substance or not.
Urinary examination
Using urinary examination is aimed to test whether the patient is using substance or not.
Urinary examination
Using urinary examination is aimed to test whether the patient is using substance or not.
Urinary examination
Using urinary examination is aimed to test whether the patient is using substance or not.

Secondary Outcome Measures

cytokines
cytokines
cytokines
cytokines
cytokines
cytokines
lipid profiles

Full Information

First Posted
August 23, 2010
Last Updated
February 27, 2013
Sponsor
National Cheng-Kung University Hospital
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01189214
Brief Title
Psychopharmacotherapy in Multiple Substances Abuse
Acronym
MM opioid
Official Title
Psychopharmacotherapy in Multiple Substances Abuse / Dependence - the Pharmacological and Immunological Approach to the New Indication of Memantine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, the investigators will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence.
Detailed Description
Opioid dependence is currently a severe problem for public health and social security. Methadone maintenance therapy may decrease the criminal rate and increase the quality of life for individuals with opioid dependence, but the high drop-out rate and long-term requirement to use of methadone are major problems in methadone maintenance therapy for opioid dependence. Methadone is after all another long acting opioid which may cause dependence. Therefore, current effort of methadone maintenance therapy is limited. Memantine used to be recognized as a noncompetitive N-methyl-D-aspartate receptor antagonist. It was found with neuroprotective effects in several neurodegenerative diseases in recent few years. Memantine could inhibit brain inflammatory response through its action on reuroglial cells and provide neurotrophic effect. Previous studies also found memantine with inhibitory effects addictive behaviors in several substances. All of the above demonstrated that the combination of memantine and methadone in treating substance dependence prossess unique advantages, which may be superior to the original treatment. The main purpose of this study is to explore the neuroprotective effect of memantine on inhibition of brain inflammatory response through its action on reuroglial cells. Besides, we will evaluate the therapeutic effect of the combination of memantine and methadone in the subjects with opioid combine amphetamine dependence/abuse. It will also investigate multiple pathogenesis of addictive behaviors from the perspective of treatment response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Memantine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Memantine
Intervention Description
Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, we will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence.
Primary Outcome Measure Information:
Title
Urinary examination
Description
Using urinary examination is aimed to test whether the patient is using substance or not.
Time Frame
baseline
Title
Urinary examination
Description
Using urinary examination is aimed to test whether the patient is using substance or not.
Time Frame
week1
Title
Urinary examination
Description
Using urinary examination is aimed to test whether the patient is using substance or not.
Time Frame
week2
Title
Urinary examination
Description
Using urinary examination is aimed to test whether the patient is using substance or not.
Time Frame
week4
Title
Urinary examination
Description
Using urinary examination is aimed to test whether the patient is using substance or not.
Time Frame
week8
Title
Urinary examination
Description
Using urinary examination is aimed to test whether the patient is using substance or not.
Time Frame
week12
Secondary Outcome Measure Information:
Title
cytokines
Time Frame
baseline
Title
cytokines
Time Frame
week1
Title
cytokines
Time Frame
week2
Title
cytokines
Time Frame
week4
Title
cytokines
Time Frame
week8
Title
cytokines
Time Frame
week12
Title
lipid profiles
Time Frame
baseline, after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patient aged ≧18 and ≦65 years. A diagnosis of opioid abuse/dependence according to DSM-IV criteria made by a specialist in psychiatry. A diagnosis of multiple drug abuse/dependence according to DSM-IV criteria made by a specialist in psychiatry. Signed informed consent by patient or legal representative Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study. Exclusion Criteria: Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study. Females who are pregnant or nursing. Patients were diagnosed as other mental illness according to DMS-IV, except Major Depressive Disorder Patient has received dextromethorphan, or other selective cyclo- oxygenase 2 (Cox-2) inhibitors, or other anti-inflammatory medication within 1 week prior to first dose of double-blind medication. Current evidence of an uncontrolled and/or clinically significant medical condition (e.g., cardiac, hepatic and renal failure), which in the judgments of the investigator, would compromise patient safety or preclude study participation. History of intolerance to valproate or memantine or other Cox-2 inhibitors. History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by memantine. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to first dose of doubleblind medication. Diagnosis of or treatment for esophageal, gastric, pyloric channel, or duodenal ulceration or related complications (bleeding and/or perforation) within 30 days prior to receiving first dose of double-blind medication. Inclusion in another study of opioid dependence or study for another indication with psychotropic's within the last 30 days prior to start of study. Increase in total SGOT, SGPT, BUN and creatinine by more than 3X ULN (upper limit of normal). History of idiopathic or drug-induced agranulocytosis. Substance-related disorders within 6 months prior to study start, borderline personality disorder, schizophrenia, or other major psychiatric disorders as defined by DSM-IV criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Band Lu, MD
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ru-Band Lu
City
Tainan
ZIP/Postal Code
704
Country
Taiwan

12. IPD Sharing Statement

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Psychopharmacotherapy in Multiple Substances Abuse

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