Psychopharmacotherapy in Multiple Substances Abuse

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cheng-Kung University Hospital
• Collaborator: National Institutes of Health (NIH)
• Treatments: Memantine

Criteria

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.