Methadone Maintenance & HIV Risk in Ukraine
Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid Dependence
Intervention: Methadone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of Pennsylvania
Summary
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.
Clinical Details
Official title: Methadone Maintenance & HIV Risk in Ukraine
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Measure the acceptability and compliance with a 3-month course of methadone maintenance in HIV+ and HIV- patients in this cultural settingMeasure the impact of a 3-month course of methadone treatment in HIV+ and HIV- on reducing opioid use Measure the impact of a 3-month course of methadone treatment in HIV+ and HIV- on reducing HIV risk behavior
Secondary outcome: Assess the degree to which the 3-month course of methadone maintenance reduces illegal activities and improves employment and psychiatric symptomsDetermine short term outcome after completion of methadone treatment Obtain pilot data on the prevalence of hepatitis B and C among study patients
Detailed description:
Approximately 40 subjects have been enrolled in this study as of September 1, 2009. Almost
all have completed the 12 week study period and elected to transfer to the regular methadone
program at the same location, that was started in the last 2 years with support from the
Global Fund. A 1-year supplement has been awarded to pilot test an intervention developed
by Dr. Dvoryak to facilitate enrollment in methadone by persons who could benefit, and an
intervention called "Life Steps" developed by Safren and colleagues and aimed to facilitate
adherence to antiretroviral therapy. A site visit was completed in 5/09 in which we
conducted two focus groups to determine local conditions that needed to be included in Life
Steps so as to make it relevant to Ukrainian cultural conditions, followed by modification
and training in the slightly revised version of Life Steps. We anticipate that the 25
additional HIV+ patients who will be enrolled to complete the supplement will start to be
enrolled in 10/09, when recruitment for the parent study has been completed.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
City AIDS Center, Kiev, Ukraine
Kiev City AIDS Center, Kiev, 115 03115, Ukraine
Additional Information
Starting date: June 2008
Last updated: January 17, 2012
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