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A Methadone Maintenance Treatment Outcome Study in Three Provinces in China

This study is currently recruiting participants.
Verified April 2012 by Centers for Disease Control and Prevention
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: April 12, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
HIV
Hepatitis C
Syphilis
Herpes Simplex Type II
 Behavioral: MMT provider dosage training
Behavioral: targeted counseling
Other: national guidelines

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 7700
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control arm
Using currently practiced methadone dosage prescription methods
 Other: national guidelines
Provided a hard copy of the existing national guidelines for methadone dosing
Other Name: dosing guidelines
Experimental: MMT provider dosage training
Intensive health care provider training on prescribing methadone dosage based on national guidelines
 Behavioral: MMT provider dosage training
Training on methadone dosing provided to health care providers working in methadone maintenance clinics
Other Name: training
Other: national guidelines
Provided a hard copy of the existing national guidelines for methadone dosing
Other Name: dosing 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 .
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315054

Contacts
Contact: Marc Bulterys, PhD 86-10-65329901 ext 222 zbe2@cdc.gov
Contact: Li Zhijun 86-10-65329901 lzj@cn.cdc.gov

Locations
China
National Center for HIV/STD Prevention and Control, China CDC Recruiting
Beijing, China, 100050
Principal Investigator: Wu Zunyou, PhD            
Principal Investigator: Marc bulterys, PhD            
Principal Investigator: Li Zhijun            
Sponsors and Collaborators
Centers for Disease Control and Prevention
National Center for AIDS/STD Control and Prevention, China CDC
Investigators
Principal Investigator: Marc Bulterys, MD, PhD US CDC GAP China
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01315054     History of Changes
Other Study ID Numbers: CDC-6014.0, CN_09_217
Study First Received: March 14, 2011
Last Updated: April 12, 2012
Health Authority: China: Institutional Review Board
United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
IDUs
high risk behaviors
HIV
MMT dosage and retention
psychosocial services

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Herpes Simplex
Syphilis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Herpesviridae Infections
DNA Virus Infections
 Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Methadone
Analgesics, Opioid
Analgesics

ClinicalTrials.gov processed this record on May 16, 2013