Opiate Dependence Clinical Trial
Official title:
Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia
Verified date | January 2018 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The long-term goals of this study are to foster development and dissemination of evidence-based behavioral and pharmacological treatments to reduce HIV transmission, injection drug use (IDU), and heroin use in Russia. This study will examine the effects of combining behavioral therapy with naltrexone pharmacotherapy for the treatment of opiate dependence and reduction of HIV risks in opiate dependent individuals. Specifically the study will determine whether extended-release injection naltrexone has greater efficacy and is more cost-effective than oral naltrexone maintenance, whether behavioral drug and HIV risk reduction counseling (BDRC) combined with brief, medical management (MM) has greater efficacy and is more cost-effective than MM only, and whether particular combinations of medication formulation and counseling (MM only or MM plus BDRC) have greater efficacy or are more cost-effective than other combinations.
Status | Completed |
Enrollment | 320 |
Est. completion date | May 2017 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Detoxified volunteers seeking drug rehabilitation treatment will be eligible for the study Exclusion Criteria: - Current suicide or homicide risk - Current psychotic disorder or major depression - Inability to understand the consent form or assessments - Pregnancy - Acute hepatitis, liver failure, or liver enzymes greater than 3 times the upper limit of normal. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Pavlov University | St. Petersburg |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Drug Abuse (NIDA), St. Petersburg State Pavlov Medical University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | reductions in sex- and drug-related HIV risk behaviors | every month during 6 months of active study phase and during the 6 month follow-up | ||
Primary | reductions in illicit opiate use (maximum consecutive days of abstinence following detoxification and number of days of heroin or illicit opiate use in the past 30 days) | every month during 6 months of active study phase and during the 6 month follow-up | ||
Primary | treatment retention (time to last clinical contact during outpatient treatment phase | 6 months | ||
Secondary | reductions in illicit use of other drugs | every month during 6 months of active study phase and during the 6 month follow-up | ||
Secondary | improvements in vocational, family, social functioning, and quality of life indices | every month during 6 months of active study phase and during the 6 month follow-up |
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