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Compare Methadone Combined With N-Acetyl-Cysteine (NAC) and Methadone Alone for Opioids Astaining (MNAC)

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ClinicalTrials.gov Identifier: NCT01047956
Recruitment Status : Unknown
Verified January 2010 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
First Posted : January 13, 2010
Last Update Posted : January 14, 2010
Sponsor:
Information provided by:
Taichung Veterans General Hospital

Brief Summary:
Evaluation whether higher retention rate is in those of combined methadone with N-Acetyl-Cysteine compared to those with methadone alone during a six-month study.

Condition or disease Intervention/treatment Phase
Opioids Use Drug: Methadone; NAC Drug: Methadone Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation Whether Higher Retention Rate is in Those of Combined Methadone With N-Acetyl-Cysteine Compared to Those With Methadone Alone During a Six-month Study
Study Start Date : June 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MethNAC
Methadone and N-acetylcysteine for opioids abstaining
Drug: Methadone; NAC
Methadone NAC

Active Comparator: Methadone
Methadone alone
Drug: Methadone
Methadone





Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 20-65 years old, all genders.
  2. Psychiatry doctor diagnosed who met DSMIV-TR criteria opioid addiction or opioid abusing.
  3. Participants need to understand procedures and assays of this experiment.
  4. Participants are willing to accept methadone substitutive abstaining program.
  5. Participants are willing to provide small amount of blood for testing.
  6. Participants are voluntarily to join interview(s), approximately 30-45min.

Exclusion Criteria:

  1. Participants have respiratory distress or other respiratory system illnesses.
  2. Participants have serious illness and possible die within 1 year or intensive care needed within 6 month.
  3. Participants have been diagnosed cardio-vascular disease recently.
  4. Participants have allergy to N-acetylcysteine.

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): NCT01047956


Contacts
Contact: Tsuo-Hung Lan, MD., PhD. 04-23592525 ext 3460
Contact: Chia-Fen Chang, MD. 04-23592525 ext 3404

Locations
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung City, Taiwan, 40705
Contact: Tsuo-Hung Lan, MD., PhD.    886-4-23592525 ext 3460    tosafish@hotmail.com   
Contact: Chia-Fen Chang, MD.    886-4-23592525 ext 3404      
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Study Director: Tsuo-Hung Lan, MD., PhD. Taichung Veterans General Hospital

Responsible Party: IRB TCVGH, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01047956     History of Changes
Other Study ID Numbers: C09075
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010

Keywords provided by Taichung Veterans General Hospital:
Methadone
NAC
opioids

Additional relevant MeSH terms:
Methadone
Acetylcysteine
N-monoacetylcystine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Antiviral Agents
Anti-Infective Agents
Expectorants
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes