Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Taichung Veterans General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01047956
First received: January 5, 2010
Last updated: January 13, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Opioids Use
Drug: Methadone; NAC
Drug: Methadone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MethNAC
Methadone and N-acetylcysteine for opioids abstaining
Drug: Methadone; NAC
Methadone NAC
Active Comparator: Methadone
Methadone alone
Drug: Methadone
Methadone

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: IRB TCVGH, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01047956     History of Changes
Other Study ID Numbers: C09075
Study First Received: January 5, 2010
Last Updated: January 13, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taichung Veterans General Hospital:
Methadone
NAC
opioids

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

ClinicalTrials.gov processed this record on November 25, 2014