Methadone Maintenance & HIV Risk in Ukraine

Opioid Dependence Clinical Trial

Official title:

Methadone Maintenance & HIV Risk in Ukraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351026
• Other study ID #: R21DA021073
• Secondary ID: R21DA021073
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2006
• Last updated: September 6, 2016
• Start date: June 2008
• Est. completion date: October 2010

Study information

• Verified date: September 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Methadone
short-term methadone maintenance

Locations

Country	Name	City	State
Ukraine	City AIDS Center	Kiev
Ukraine	Kiev City AIDS Center	Kiev

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the acceptability and compliance with a 3-month course of methadone maintenance in HIV+ and HIV- patients in this cultural setting		3 months	Yes
Primary	Measure the impact of a 3-month course of methadone treatment in HIV+ and HIV- on reducing opioid use		3 months	Yes
Primary	Measure the impact of a 3-month course of methadone treatment in HIV+ and HIV- on reducing HIV risk behavior		3 months	Yes
Secondary	Assess the degree to which the 3-month course of methadone maintenance reduces illegal activities and improves employment and psychiatric symptoms		3 months	Yes
Secondary	Determine short term outcome after completion of methadone treatment		3 months	Yes
Secondary	Obtain pilot data on the prevalence of hepatitis B and C among study patients		3 months	Yes