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Combined Therapy of Methadone and Dextromethrophan (DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189097
Recruitment Status : Unknown
Verified August 2010 by National Cheng-Kung University Hospital.
Recruitment status was:  Recruiting
First Posted : August 26, 2010
Last Update Posted : August 26, 2010
Sponsor:
Information provided by:
National Cheng-Kung University Hospital

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.


Condition or disease Intervention/treatment Phase
Opioid Abuse Drug: Dextromethorphan Phase 3

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 DM/placebo 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 DM/placebo 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 DM/placebo add-on treatment for three months will be performed in the end of first year.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Therapy of Methadone and Dextromethrophan: A Novel Strategy for the Treatment of Opioid Dependence
Study Start Date : April 2008
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : September 2011


Arm Intervention/treatment
Experimental: dextromethorphan Drug: Dextromethorphan
Subjects who have not used opioid for at least one week before baseline evaluation will take one-week placebo for the wash-out period first and then will be categorized into the opioid free group. The subjects of the opioid using group will be assigned randomly into the following six groups: 1) Methadone + DM 60mg; 2) Methadone + DM 120mg; 3) Methadone + Placebo; 4) Methadone + DM 60mg + motivation and cognitive behavior therapy; 5) Methadone + DM 120mg + motivation and cognitive behavior therapy; 6) Methadone + Placebo + motivation and cognitive behavior therapy. The opioid free group will be 1) DM 30mg; 2) DM 60 mg; 3) Placebo.

Drug: Dextromethorphan
Subjects who have not used opioid for at least one week before baseline evaluation will take one-week placebo for the wash-out period and then randomly assigned into six groups: 1) Methadone + DM 60mg; 2) Methadone + DM 120mg; 3) Methadone + Placebo; 4) Methadone + DM 60mg + motivation and cognitive behavior therapy; 5) Methadone + DM 120mg + motivation and cognitive behavior therapy; 6) Methadone + Placebo + motivation and cognitive behavior therapy. The opioid free group will be 1) DM 30mg; 2) DM 60 mg; 3) Placebo. If the subjects of the opioid free group suffer from relapses and begin to use heroin, they will receive methadone treatment. The dosage of methadone will be increased or decreased maximal 5 mg each time as necessary.




Primary Outcome Measures :
  1. Urinary examination [ Time Frame: baseline ]
    Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.

  2. Urinary examination [ Time Frame: week 1 ]
    Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.

  3. Urinary examination [ Time Frame: week2 ]
    Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.

  4. Urinary examination [ Time Frame: week4 ]
    Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.

  5. Urinary examination [ Time Frame: week8 ]
    Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.

  6. Urinary examination [ Time Frame: week12 ]
    Using urinary examination is aimed to test whether the drug dependence is still using morphine or not.


Secondary Outcome Measures :
  1. cytokines [ Time Frame: baseline ]
  2. cytokines [ Time Frame: week1 ]
  3. cytokines [ Time Frame: week2 ]
  4. cytokines [ Time Frame: week4 ]
  5. cytokines [ Time Frame: week8 ]
  6. cytokines [ Time Frame: week12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189097


Contacts
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Contact: Ru-Band Lu, MD +886-6-2353535 ext 5108 rblu@mail.ncku.edu.tw

Locations
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Taiwan
Ru-Band Lu Recruiting
Tainan, Taiwan, 704
Contact: Ru-Band Lu, MD    +886-6-2353535 ext 5108    rblu@mail.ncku.edu.tw   
Principal Investigator: Ru-Band Lu, MD         
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
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Principal Investigator: Ru-Band Lu, MD National Cheng-Kung University Hospital

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Responsible Party: Ru-Band Lu/Professor, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01189097    
Other Study ID Numbers: HR-95-139
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: August 26, 2010
Last Verified: August 2010
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Dextromethorphan
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action