HIV Infections Clinical Trial
Official title:
HIV Risk Reduction and Drug Abuse Treatment in Iran
Verified date | July 2013 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance treatment when combined with drug abuse and HIV risk reduction counseling (DC-HIV) for heroin and opium addicts in Iran.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2008 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Opioid Dependence Exclusion Criteria: - Dependence on alcohol, benzodiazepines or sedatives - Suicide or homicide risk - Psychotic disorder or major depression - Inability to read or understand the protocol or assessment questions - Life-threatening or unstable medical problems - Greater than 3 times normal liver enzymes (AST, GGT) |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Institute for Cognitive Studies | Tehran | |
United States | Yale University School of Medicine | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Drug Abuse (NIDA) |
United States, Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to resumption of heroin use | 26 weeks | ||
Primary | Time to relapse | 26 weeks | ||
Primary | Maximum consecutive weeks of opiate abstinence | 26 weeks | ||
Primary | Reduction of HIV risks | 26 weeks | ||
Secondary | Addiction-related functional status | 26 weeks | ||
Secondary | Adverse events | 26 weeks |
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