Opiate Dependence Clinical Trial
Official title:
Behavioral Drug and HIV Risk Reduction Counseling With MMT in China
Verified date | March 2020 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will provide critical data regarding the efficacy for reducing drug-and sex-related HIV transmission risk behaviors, as well as improving methadone maintenance treatment (MMT) outcomes and patient functioning of two transportable counseling models, behavioral drug and HIV risk reduction counseling (BDRC) and educational counseling (EC) as compared with the current standard of care model in MMT in China. Evidence-based counseling that is efficacious in reducing HIV risks and drug use and is feasible to provide with MMT will greatly improve the public health benefits of disseminating MMT in China and elsewhere in the world.
Status | Completed |
Enrollment | 300 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - treatment seeking volunteers meeting DSM-IV criteria for opiate dependence, as assessed by SCID interview and documented by opioid positive urine toxicology testing, entering MMT in Wuhan. China Exclusion Criteria: - current dependence on alcohol, benzodiazepines or sedatives - current suicide or homicide risk - current psychotic disorder or major depression - inability to understand the protocol or assessment questions |
Country | Name | City | State |
---|---|---|---|
China | Center for Disease Control & Prevention | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Yale University | Centers for Disease Control and Prevention, China, National Institute on Drug Abuse (NIDA) |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of drug- and sex-related HIV risk behaviors | drug-related and sex-related HIV risk behaviors will be assessed by audio computer-assisted self-interview | Up to 10 months | |
Primary | Reduction of frequency (days of illicit opiate use in each month) of heroin or other illicit opiate use | days of illicit opiate use in each month will be based on self report and urine toxicology tests | Up to 10 months | |
Secondary | Treatment retention | Treatment retention is defined as time in treatment from the treatment entry to treatment completion or discontinuation | at 16 weeks | |
Secondary | Reductions in other illicit drug use | Reductions in other illicit drug use are based on self-report and urine toxicology screens | Up to 10 months | |
Secondary | Improvements of functional status (e.g., in vocational, family, and social functioning, and healthcare and other resource utilization) | Improvements of functional status are based on the results of Addiction Severity Index assessment instrument | Up to 10 months |
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