Combined Therapy of Methadone and Dextromethrophan

• Status: Unknown status
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the pharmacological effects and outcomes of DM therapy with this add-on study.

And to determine the immunological changes between the baseline and the end point of the study.

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

Details

• Lead Sponsor: National Cheng-Kung University Hospital
• Treatments: Dextromethorphan; Methadone

Criteria

Inclusion Criteria:

1. Signed informed consent by patient or legal representative.

2. Male or female patient aged ≧18 and ≦65 years.

3. A diagnosis of opioid dependence according to DSM-IV criteria made by a specialist in psychiatry.

4. 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 the duration of the study.

2. Females who are pregnant or nursing.

3. Patient has received DM or other anti-inflammatory medications within 1 week prior to the first dose of the double-blinded medication.

4. Other major Axis-I DSM-IV diagnosis other than opioid dependence such as multiple substance dependence within 1 year prior to the fist dose of the double-blinded medication.

5. Current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation.

6. History of intolerance to methadone or DM.

7. History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) to DM.

8. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first dose of the double-blinded medication.

9. Increase in total SGOT, SGPT, gamma-GT, BUN and creatinine by more than 3X ULN (upper limit of normal).