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CompletedNCT01315054Updated Aug 22, 2024

A Methadone Maintenance Treatment Outcome Study in Three Provinces in China

An interventional study of MMT provider dosage training and targeted counseling in HIV, Hepatitis C and Syphilis, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by Centers for Disease Control and Prevention · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
4,258
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • HIV
  • Hepatitis C
  • Syphilis
  • Herpes Simplex Type II

Keywords

  • IDUs
  • high risk behaviors
  • HIV
  • MMT dosage and retention
  • psychosocial services
03

In context

Hepatitis C

2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.

This study's enrollment of 4,258 is above the median of 79 across 1,660 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,258 participants (actual)

Study arms

  • Other
    Control arm

    Using currently practiced methadone dosage prescription methods

    Other: national guidelines

  • Experimental
    MMT provider dosage training

    Intensive health care provider training on prescribing methadone dosage based on national guidelines

    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 .

    Behavioral: MMT provider dosage training · Behavioral: targeted counseling · Other: national guidelines

Interventions

  • BehavioralMMT provider dosage training

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

    Also known as: training

  • Behavioraltargeted counseling

    targeted counseling provided to methadone maintenance clinic attendees

    Also known as: counseling

  • Othernational guidelines

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

    Also known as: dosing guidelines

06

What researchers measure

Primary outcomes

  1. MMT retention rate

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

    Time frame: 12 months

  2. Illicit opioid use rate

    by urinalysis and self-report

    Time frame: 12 months

Secondary outcomes

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

    Patients who were negative converted to being seropositive

    Time frame: 12 months

  2. High risk needle practice

    Shared needles used for drug injections without cleaning procedures involved

    Time frame: 12 months

  3. High risk sexual practice

    Sex without condoms and also with multiple partners

    Time frame: 12 months

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

    Scale of quality of life by WHO

    Time frame: 12 months

  5. All-cause mortality

    Patients die by all causes during the program

    Time frame: 12 months

07

Study locations

1 site
  • National Center for HIV/STD Prevention and Control, China CDC
    Beijing, 100050, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01315054
Collaborators
National Center for AIDS/STD Control and Prevention, China CDC
Responsible party
Sponsor
First posted
Mar 15, 2011
Start date
May 2011
Primary completion
Dec 2015
Completion
Dec 2018
Last update
Aug 22, 2024

Study contacts

Marc Bulterys, MD, PhD
principal investigator · US CDC GAP China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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