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Completed

NCT Number: NCT01315054

A Methadone Maintenance Treatment Outcome Study in Three Provinces in China

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.

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Key information

Conditions

HIV Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases Gram-Negative Bacterial Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Herpes Simplex Type II Infections Liver Diseases RNA Virus Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Spirochaetales Infections Syphilis Treponemal Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, 100050, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MMT provider dosage training

Behavioral

Training on methadone dosing provided to health care providers working in methadone maintenance clinics

Other names: training

targeted counseling

Behavioral

targeted counseling provided to methadone maintenance clinic attendees

Other names: counseling

National guidelines

Other

Provided a hard copy of the existing national guidelines for methadone dosing

Other names: dosing guidelines

Primary outcomes

  1. MMT retention rate

    Time frame: 12 months

    % of patients retained at the end of the year after Methadone maintenance treatment

  2. Illicit opioid use rate

    Time frame: 12 months

    by urinalysis and self-report

Secondary outcomes

  1. HIV, HCV, syphilis and HSV-2 infection seroconversion rate

    Time frame: 12 months

    Patients who were negative converted to being seropositive

  2. High risk needle practice

    Time frame: 12 months

    Shared needles used for drug injections without cleaning procedures involved

  3. High risk sexual practice

    Time frame: 12 months

    Sex without condoms and also with multiple partners

  4. Quality of life（WHO Quality of Life -BREF）

    Time frame: 12 months

    Scale of quality of life by WHO

  5. All-cause mortality

    Time frame: 12 months

    Patients die by all causes during the program

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2015
Study completion
2018
First posted
Mar 15, 2011
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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