Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

A Methadone Maintenance Treatment Outcome Study in Three Provinces in China

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Centers for Disease Control and Prevention.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Center for AIDS/STD Control and Prevention, China CDC
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01315054
First received: March 14, 2011
Last updated: March 13, 2014
Last verified: April 2012
History of Changes

March 14, 2011
March 13, 2014
May 2011
December 2014   (final data collection date for primary outcome measure)
  • MMT retention rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Illicit opioid use rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    by urinalysis and self-report
Same as current
Complete list of historical versions of study NCT01315054 on ClinicalTrials.gov Archive Site
  • HIV, HCV, syphilis and HSV-2 infection seroconversion rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • High risk needle practice [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • High risk sexual practice [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life（WHO Quality of Life -BREF） [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Methadone Maintenance Treatment Outcome Study in Three Provinces in China
A Methadone Maintenance Treatment Outcome Study in Three Provinces in China: Comparative Evaluation of the Impact of an Intensive Health Care Provider Training Program Combined With Expanded Services on Treatment Retention, Heroin Use, Methadone Dosing and HIV Risk Practices
Methadone treatment has became one of main actions taken in China to control the spread of HIV among drug users. However，the average methadone dose used is relatively low. An intensive methadone maintenance treatment (MMT) provider training on methadone dosage may be effective in increasing the methadone dose levels prescribed to new patients. The study will evaluate the effectiveness of a tailored education program for MMT service providers using subsequent methadone dose prescribed to new patients. The effects of methadone dose, with and without the inclusion of additional psychosocial services, will then be measured through MMT retention and illicit opioid use.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • HIV
  • Hepatitis C
  • Syphilis
  • Herpes Simplex Type II
  • Behavioral: MMT provider dosage training
    Training on methadone dosing provided to health care providers working in methadone maintenance clinics
    Other Name: training
  • Behavioral: targeted counseling
    targeted counseling provided to methadone maintenance clinic attendees
    Other Name: counseling
  • Other: national guidelines
    Provided a hard copy of the existing national guidelines for methadone dosing
    Other Name: dosing guidelines
  • Control arm
    Using currently practiced methadone dosage prescription methods
    Intervention: Other: national guidelines
  • Experimental: MMT provider dosage training
    Intensive health care provider training on prescribing methadone dosage based on national guidelines
    Interventions:
    • Behavioral: MMT provider dosage training
    • Other: national guidelines
  • Experimental: MMT provider dosage training/counseling
    Intensive health care provider training on prescribing methadone dosage, plus providing on-site psychosocial counseling services and peer support to clients .
    Interventions:
    • Behavioral: MMT provider dosage training
    • Behavioral: targeted counseling
    • Other: national guidelines
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
7700
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • client participants will include both men and women who are opiate-dependent drug users who started MMT not more than one month prior to enrollment in the study
  • 18 years of age or older
  • residing in the study areas
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01315054
CDC-CGH-6014, CN_09_217
Yes
Not Provided
Not Provided
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
National Center for AIDS/STD Control and Prevention, China CDC
Principal Investigator: Marc Bulterys, MD, PhD US CDC GAP China
Centers for Disease Control and Prevention
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP