A Methadone Maintenance Treatment Outcome Study in Three Provinces in China

August 20, 2024 updated by: Centers for Disease Control and Prevention

A Methadone Maintenance Treatment Outcome Study in Three Provinces in China: Comparative Evaluation of the Impact of an Intensive Health Care Provider Training Program

The primary goal of this PHE is to determine the effectiveness of a tailored education program for MMT service providers. It was to be evaluated through methadone dose levels prescribed to new patients after training completion. The effects of methadone dose, with and without the inclusion of additional counseling services, would be measured through MMT retention and illicit opioid use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

4258

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100050
        • National Center for HIV/STD Prevention and Control, China CDC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • dosing guidelines
Experimental: MMT provider dosage training
Intensive health care provider training on prescribing methadone dosage based on national guidelines
Other: national guidelines
Provided a hard copy of the existing national guidelines for methadone dosing
Other Names:
  • dosing guidelines
Behavioral: MMT provider dosage training
Training on methadone dosing provided to health care providers working in methadone maintenance clinics
Other Names:
  • training
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 .
Other: national guidelines
Provided a hard copy of the existing national guidelines for methadone dosing
Other Names:
  • dosing guidelines
Behavioral: MMT provider dosage training
Training on methadone dosing provided to health care providers working in methadone maintenance clinics
Other Names:
  • training
Behavioral: targeted counseling
targeted counseling provided to methadone maintenance clinic attendees
Other Names:
  • counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Illicit opioid use rate
Time Frame: 12 months
by urinalysis and self-report
12 months
MMT retention rate
Time Frame: 12 months
% of patients retained at the end of the year after Methadone maintenance treatment
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV, HCV, syphilis and HSV-2 infection seroconversion rate
Time Frame: 12 months
Patients who were negative converted to being seropositive
12 months
High risk needle practice
Time Frame: 12 months
Shared needles used for drug injections without cleaning procedures involved
12 months
High risk sexual practice
Time Frame: 12 months
Sex without condoms and also with multiple partners
12 months
Quality of life（WHO Quality of Life -BREF）
Time Frame: 12 months
Scale of quality of life by WHO
12 months
All-cause mortality
Time Frame: 12 months
Patients die by all causes during the program
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

National Center for AIDS/STD Control and Prevention, China CDC

Investigators

  • Principal Investigator: Marc Bulterys, MD, PhD, US CDC GAP China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

March 14, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimated)

March 15, 2011

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-CGH-6014
  • CN_09_217 (Other Grant/Funding Number: OGAC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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