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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00351026 |
Purpose
Treatment of opioid dependence is an important way to reduce the spread of HIV and other infectious diseases, particularly in Ukraine since intravenous opioid use is the major way these infections are being spread. This proposal will be done at the Kiev City Narcology Hospital and the City AIDS Center with collaborators from the University of Alabama and the University of Colorado. It will study the acceptability and impact of a 3-month course of methadone maintenance on 50 persons with opioid dependence, 25 who are HIV+ and 25 HIV-. The proposed work will build on a relationship that was established with the Ukrainian Co-Principal Investigator, Sergiy Dvoryak, M.D., during his Humphrey Fellowship at Johns Hopkins in 1999-2000 when he spent time with Dr. Woody and Metzger at the Penn Addiction and Treatment and Research Center. It will also extend studies of pharmacologic treatment for opioid dependence and risk reduction behavioral interventions that are being done by Drs. Woody, Schumacher and Booth in Russia and Ukraine. Primary aims are to: measure the acceptability and compliance with a 3-month course of methadone maintenance in HIV+ and HIV- patients; measure the impact of a 3-month course of methadone in reducing opioid use in HIV+ and HIV- patients; measure the impact of a 3-month course of methadone on reducing HIV risk behavior in HIV+_and HIV- patients. Secondary aims are to: assess the degree to which a 3-month course of methadone maintenance reduces illegal activities and improves employment and psychiatric symptoms; determine short-term outcome after completion of methadone treatment; and obtain pilot data on the prevalence of hepatitis B and C among study patients. This study will provide pilot data on the acceptability and efficacy of a short-term course of methadone maintenance on HIV+ and HIV- persons in a setting where this treatment has not been evaluated, on the feasibility of conducting the kind of work that is proposed, and will enhance research capabilities of Kiev investigators for future HIV prevention and treatment studies.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid Dependence |
Drug: Methadone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | Methadone Maintenance & HIV Risk in Ukraine |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
25 HIV negative opiate dependent patients all treated with methadone
|
Drug: Methadone
short-term methadone maintenance
|
|
2: Active Comparator
25 HIV positive opiate dependent patients all treated with methadone
|
Drug: Methadone
short-term methadone maintenance
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Primary diagnosis of current opioid dependence with physiological features, present for at least one year and seeking outpatient treatment.
Age between 18 and 40 Stable address within Kiev and not planning to move Home telephone number where can be reached Willingness and ability to give informed consent and otherwise participate
Exclusion Criteria:
Clinically significant cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder, or seizure disorder Advanced neurological, cardiovascular, renal, hepatic or other medical disorder that would seriously impair or make hazardous patient's ability to participate Active tuberculosis Currently dependent on alcohol, benzodiazepines or other sedative-like drugs Pending legal charges with potential impending incarceration Plans to move from the area within the next 6 months Concurrent participation in another treatment study
Contacts and Locations| Ukraine | |
| City AIDS Center | Recruiting |
| Kiev, Ukraine | |
| Contact: Olexander Yurchenko, MD (38044) 4509314 common@socio.kiev.ua | |
| Ukraine, 115 | |
| Kiev City AIDS Center | Recruiting |
| Kiev, 115, Ukraine, 03115 | |
| Contact: Olexander Yurchenko, MD (38044) 4509314 common@socio.kiev.ua | |
| Principal Investigator: Anatoliy M Viyevskiy, M.D., Ph.D. | |
| Sub-Investigator: Sergiy Dvoryak, M.D., Ph.D. | |
More Information
| Responsible Party: | University of Pennsylvania ( Office of Research Services ) |
| Study ID Numbers: | R21 DA021073, R21 DA021073 |
| Study First Received: | July 10, 2006 |
| Last Updated: | February 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00351026 History of Changes |
| Health Authority: | United States: Federal Government |
|
opioid dependence methadone HIV |
|
Acquired Immunodeficiency Syndrome Disorders of Environmental Origin Central Nervous System Depressants Narcotics Opioid-Related Disorders Naphazoline Methadone HIV Infections |
Mental Disorders Guaifenesin Substance-Related Disorders Peripheral Nervous System Agents Phenylpropanolamine Analgesics Analgesics, Opioid |
|
Respiratory System Agents Physiological Effects of Drugs Disorders of Environmental Origin Central Nervous System Depressants Narcotics Opioid-Related Disorders Pharmacologic Actions Methadone Sensory System Agents |
Mental Disorders Therapeutic Uses Substance-Related Disorders Peripheral Nervous System Agents Analgesics Antitussive Agents Central Nervous System Agents Analgesics, Opioid |
