A Methadone Maintenance Treatment Outcome Study in Three Provinces in China

Tracking Information
First Submitted Date ICMJE	March 14, 2011
First Posted Date ICMJE	March 15, 2011
Last Update Posted Date	March 17, 2014
Study Start Date ICMJE	May 2011
Estimated Primary Completion Date	December 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 14, 2011)	MMT retention rate [ Time Frame: 12 months ]; Illicit opioid use rate [ Time Frame: 12 months ]by urinalysis and self-report
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01315054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 14, 2011)	HIV, HCV, syphilis and HSV-2 infection seroconversion rate [ Time Frame: 12 months ]; High risk needle practice [ Time Frame: 12 months ]; High risk sexual practice [ Time Frame: 12 months ]; Quality of life（WHO Quality of Life -BREF） [ Time Frame: 12 months ]; All-cause mortality [ Time Frame: 12 months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Methadone Maintenance Treatment Outcome Study in Three Provinces in China
Official Title ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
Condition ICMJE	HIV; Hepatitis C; Syphilis; Herpes Simplex Type II
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: March 14, 2011)	7700
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2014
Estimated Primary Completion Date	December 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	China
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01315054
Other Study ID Numbers ICMJE	CDC-CGH-6014; CN_09_217 ( Other Grant/Funding Number: OGAC )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Centers for Disease Control and Prevention
Study Sponsor ICMJE	Centers for Disease Control and Prevention
Collaborators ICMJE	National Center for AIDS/STD Control and Prevention, China CDC
Investigators ICMJE	Principal Investigator: Marc Bulterys, MD, PhD US CDC GAP China
PRS Account	Centers for Disease Control and Prevention
Verification Date	April 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP