A Methadone Maintenance Treatment Outcome Study in Three Provinces in China

This study is ongoing, but not recruiting participants.
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
  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:


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 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: NCT01315054

Locations
China
National Center for HIV/STD Prevention and Control, China CDC
Beijing, China, 100050
Sponsors and Collaborators
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-CGH-6014, CN_09_217
Study First Received: March 14, 2011
Last Updated: March 13, 2014
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 C
Herpes Simplex
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 29, 2014