Status:
UNKNOWN
Combined Therapy of Methadone and Dextromethrophan
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Opioid Abuse
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 po...
Detailed Description
Opioid dependence is a severe public health problem. Current efforts to taper individuals off opioid medications are limited due to a high relapse rate and lack of efficacy in relieving subjective sym...
Eligibility Criteria
Inclusion
- Signed informed consent by patient or legal representative.
- Male or female patient aged ≧18 and ≦65 years.
- A diagnosis of opioid dependence according to DSM-IV criteria made by a specialist in psychiatry.
- Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.
Exclusion
- 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.
- Females who are pregnant or nursing.
- Patient has received DM or other anti-inflammatory medications within 1 week prior to the first dose of the double-blinded medication.
- 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.
- 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.
- History of intolerance to methadone or DM.
- History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) to DM.
- Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first dose of the double-blinded medication.
- Increase in total SGOT, SGPT, gamma-GT, BUN and creatinine by more than 3X ULN (upper limit of normal).
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT01189097
Start Date
April 1 2008
End Date
September 1 2011
Last Update
August 26 2010
Active Locations (1)
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1
Ru-Band Lu
Tainan, Taiwan, 704