- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01315054
A Methadone Maintenance Treatment Outcome Study in Three Provinces in China
March 13, 2014 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 Combined With Expanded Services on Treatment Retention, Heroin Use, Methadone Dosing and HIV Risk Practices
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
7700
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
-
-
-
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
Genders Eligible for Study
All
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
|
Provided a hard copy of the existing national guidelines for methadone dosing
Other Names:
|
Experimental: MMT provider dosage training
Intensive health care provider training on prescribing methadone dosage based on national guidelines
|
Provided a hard copy of the existing national guidelines for methadone dosing
Other Names:
Training on methadone dosing provided to health care providers working in methadone maintenance clinics
Other Names:
|
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 .
|
Provided a hard copy of the existing national guidelines for methadone dosing
Other Names:
Training on methadone dosing provided to health care providers working in methadone maintenance clinics
Other Names:
targeted counseling provided to methadone maintenance clinic attendees
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MMT retention rate
Time Frame: 12 months
|
12 months
|
|
Illicit opioid use rate
Time Frame: 12 months
|
by urinalysis and self-report
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All-cause mortality
Time Frame: 12 months
|
12 months
|
HIV, HCV, syphilis and HSV-2 infection seroconversion rate
Time Frame: 12 months
|
12 months
|
High risk needle practice
Time Frame: 12 months
|
12 months
|
High risk sexual practice
Time Frame: 12 months
|
12 months
|
Quality of life(WHO Quality of Life -BREF)
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
March 14, 2011
First Submitted That Met QC Criteria
March 14, 2011
First Posted (Estimate)
March 15, 2011
Study Record Updates
Last Update Posted (Estimate)
March 17, 2014
Last Update Submitted That Met QC Criteria
March 13, 2014
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- DNA Virus Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Skin Diseases, Viral
- Herpesviridae Infections
- Hepatitis
- Sexually Transmitted Diseases, Bacterial
- Spirochaetales Infections
- Treponemal Infections
- Hepatitis C
- Herpes Simplex
- Syphilis
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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