Psychopharmacotherapy in Multiple Substances Abuse

NCT01189214 | Completed Phase 3 DMC

• 2 other identifiers: Opioid MM-2009Taiwan NIH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Abuse

Outcome Measures

Primary Outcomes (6)

• Urinary examination

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

  baseline

• Urinary examination

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

  week1

• Urinary examination

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

  week2

• Urinary examination

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

  week4

• Urinary examination

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

  week8

• Urinary examination

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

  week12

Secondary Outcomes (7)

• cytokines

  baseline

• cytokines

  week1

• cytokines

  week2

• cytokines

  week4

• cytokines

  week8

Study Arms (1)

Memantine

EXPERIMENTAL

Drug: Memantine

Interventions

Memantine DRUG

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.

Memantine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Ru-Band Lu

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Memantine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ru-Band Lu, MD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 26, 2010
• Study Start: March 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 28, 2013

Record last verified: 2010-08

Locations

TW (1)