Substance AbusePhase 3MM opioidNCT01189214
Psychopharmacotherapy in Multiple Substances Abuse
A Phase 3 study testing Memantine in people with Substance Abuse, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Memantine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2009to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychopharmacotherapy in Multiple Substances Abuse / Dependence - the Pharmacological and Immunological Approach to the New Indication of Memantine
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.
Read the 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.
- Conditions
- Substance Abuse
- Being tested
- Memantine
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Memantine | Experimental | Not described Receives: Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary examination
Using urinary examination is aimed to test whether the patient is using substance or not.
Measured: baseline
Urinary examination
Using urinary examination is aimed to test whether the patient is using substance or not.
Measured: week1
Urinary examination
Using urinary examination is aimed to test whether the patient is using substance or not.
Measured: week2
Urinary examination
Using urinary examination is aimed to test whether the patient is using substance or not.
Measured: week4
Urinary examination
Using urinary examination is aimed to test whether the patient is using substance or not.
Measured: week8
Urinary examination
Using urinary examination is aimed to test whether the patient is using substance or not.
Measured: week12
Secondary outcomes (7)
cytokines
Measured: baseline
cytokines
Measured: week1
cytokines
Measured: week2
cytokines
Measured: week4
cytokines
Measured: week8
cytokines
Measured: week12
lipid profiles
Measured: baseline, after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startMar 2009
- Primary completionFeb 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Ru-Band Lu, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189214
- Sponsor's protocol ID
- Opioid MM-2009
- Other IDs
- Taiwan NIH
- Acronym
- MM opioid
- Status last verified
- Aug 2010
- First submitted
- 23 Aug 2010
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychopharmacotherapy in Multiple Substances Abuse / Dependence - the Pharmacological and Immunological Approach to the New Indication of Memantine
- ClinicalTrials.gov ID
- NCT01189214
- Acronym / sponsor ID
- MM opioid / Opioid MM-2009
- Conditions
- Substance Abuse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Mar 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memantine | Experimental | Drug: Memantine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemantineAdd-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. | Drug | Memantine |
Primary outcome
Urinary examination
Time frame: baseline
Using urinary examination is aimed to test whether the patient is using substance or not.
Urinary examination
Time frame: week1
Using urinary examination is aimed to test whether the patient is using substance or not.
Urinary examination
Time frame: week2
Using urinary examination is aimed to test whether the patient is using substance or not.
Urinary examination
Time frame: week4
Using urinary examination is aimed to test whether the patient is using substance or not.
Urinary examination
Time frame: week8
Using urinary examination is aimed to test whether the patient is using substance or not.
Urinary examination
Time frame: week12
Using urinary examination is aimed to test whether the patient is using substance or not.
7 secondary outcomes
cytokines
Time frame: baseline
cytokines
Time frame: week1
cytokines
Time frame: week2
cytokines
Time frame: week4
cytokines
Time frame: week8
cytokines
Time frame: week12
lipid profiles
Time frame: baseline, after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ru-Band Lu, MD principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Memantine in people with Substance Abuse, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary examination (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2013.