Ignite Creation Date:
2024-05-05 @ 10:46 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01189097
Status:
UNKNOWN
Last Update Posted:
2010-08-26
First Post:
2010-08-23
Brief Title:
Combined Therapy of Methadone and Dextromethrophan
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
Combined Therapy of Methadone and Dextromethrophan A Novel Strategy for the Treatment of Opioid Dependence
Status:
UNKNOWN
Status Verified Date:
2010-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DM
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 point of the study
And to determine the immunological changes between the baseline and the end point of the study
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 symptoms Methadone substitution therapies might decrease the criminal rate and increase the quality of life for individuals with opioid dependence but the high drop-out rate and continuing use of methadone are major problems in the maintenance of therapy for opioid dependence Studies in the pathogenesis of opioid dependence and additional behaviors need more focused attention
Dextromethorphan DM is a noncompetitive N-methyl-D-aspartate receptor antagonist that has proven safety record for anti-tussive purpose Previous studies demonstrated that DM may be useful in decreasing craving in animals Huang et al 2003 Lue et al 2007 and withdrawal tendencies in human with opioid dependence In recent studies DM has been reported to afford neuroprotection against endotoxin-induced dopaminergic neurotoxicity Li et al 2005 Liu et al 2003 Zhang et al 2004 2005 which might be related to treatment for additictive behaviors The purposes of this study are to examine whether DM is able to 1 reduce opioid tolerance and decrease methadone use 2 reduce withdrawal symptoms 3 decrease the relapse rate of opioid use and 4 be an effective treatment for opioid dependence and addictive behaviors
This is a double-blinded placebo-controlled randomized and parallel groups clinical research trial study Subjects with opioid dependence are recruited from two different sources One group will come from the list of current opioid users and will be required to stay on methadone treatment opioid using group and the second group will come from subjects who are forced to discontinue opioid use for more than one week opioid free group
In the opioid using group add-on of DM or placebo treatment will proceed in a double-blind fashion for 12 weeks after completed structured diagnostic interview and adjusted methadone dose In the opioid free group subjects will take one-week placebo for the wash-out period first and then will be admitted into a double-blind DMplacebo only for 12 weeks Both opioid using and opioid free groups will be examined weekly through urine tests for opioid use and will be assessed on a craving scale after the completion of the structured diagnostic interviews We will measure the treatment response and side effects to clarify the curative effects of DM with the use of the double-blinded DMplacebo therapy design in both the opioid using and opioid free groups Several psychological examinations psychosocial questionnaires tests for immune parameters electrophysiological studies and genetic markers will be performed in this study The interim analysis and decording of partial subjects who completed DMplacebo add-on treatment for three months will be performed in the end of first year
Dextromethorphan DM is a noncompetitive N-methyl-D-aspartate receptor antagonist that has proven safety record for anti-tussive purpose Previous studies demonstrated that DM may be useful in decreasing craving in animals Huang et al 2003 Lue et al 2007 and withdrawal tendencies in human with opioid dependence In recent studies DM has been reported to afford neuroprotection against endotoxin-induced dopaminergic neurotoxicity Li et al 2005 Liu et al 2003 Zhang et al 2004 2005 which might be related to treatment for additictive behaviors The purposes of this study are to examine whether DM is able to 1 reduce opioid tolerance and decrease methadone use 2 reduce withdrawal symptoms 3 decrease the relapse rate of opioid use and 4 be an effective treatment for opioid dependence and addictive behaviors
This is a double-blinded placebo-controlled randomized and parallel groups clinical research trial study Subjects with opioid dependence are recruited from two different sources One group will come from the list of current opioid users and will be required to stay on methadone treatment opioid using group and the second group will come from subjects who are forced to discontinue opioid use for more than one week opioid free group
In the opioid using group add-on of DM or placebo treatment will proceed in a double-blind fashion for 12 weeks after completed structured diagnostic interview and adjusted methadone dose In the opioid free group subjects will take one-week placebo for the wash-out period first and then will be admitted into a double-blind DMplacebo only for 12 weeks Both opioid using and opioid free groups will be examined weekly through urine tests for opioid use and will be assessed on a craving scale after the completion of the structured diagnostic interviews We will measure the treatment response and side effects to clarify the curative effects of DM with the use of the double-blinded DMplacebo therapy design in both the opioid using and opioid free groups Several psychological examinations psychosocial questionnaires tests for immune parameters electrophysiological studies and genetic markers will be performed in this study The interim analysis and decording of partial subjects who completed DMplacebo add-on treatment for three months will be performed in the end of first year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None