- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01189214
Psychopharmacotherapy in Multiple Substances Abuse (MM opioid)
Psychopharmacotherapy in Multiple Substances Abuse / Dependence - the Pharmacological and Immunological Approach to the New Indication of Memantine
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Tainan, Taiwan, 704
- Ru-Band Lu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Memantine
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary examination
Time Frame: baseline
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Using urinary examination is aimed to test whether the patient is using substance or not.
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baseline
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Urinary examination
Time Frame: week1
|
Using urinary examination is aimed to test whether the patient is using substance or not.
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week1
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Urinary examination
Time Frame: week2
|
Using urinary examination is aimed to test whether the patient is using substance or not.
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week2
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Urinary examination
Time Frame: week4
|
Using urinary examination is aimed to test whether the patient is using substance or not.
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week4
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Urinary examination
Time Frame: week8
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Using urinary examination is aimed to test whether the patient is using substance or not.
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week8
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Urinary examination
Time Frame: week12
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Using urinary examination is aimed to test whether the patient is using substance or not.
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week12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
lipid profiles
Time Frame: baseline, after treatment
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baseline, after treatment
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cytokines
Time Frame: baseline
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baseline
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cytokines
Time Frame: week1
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week1
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cytokines
Time Frame: week2
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week2
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cytokines
Time Frame: week4
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week4
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cytokines
Time Frame: week8
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week8
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cytokines
Time Frame: week12
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week12
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- Opioid MM-2009
- Taiwan NIH (OTHER_GRANT: DOH98-TD-I-111-DD004)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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