Methadone Maintenance & HIV Risk in Ukraine

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00351026
First received: July 10, 2006
Last updated: January 17, 2012
Last verified: January 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Methadone Maintenance & HIV Risk in Ukraine

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Measure the acceptability and compliance with a 3-month course of methadone maintenance in HIV+ and HIV- patients in this cultural setting [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Measure the impact of a 3-month course of methadone treatment in HIV+ and HIV- on reducing opioid use [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Measure the impact of a 3-month course of methadone treatment in HIV+ and HIV- on reducing HIV risk behavior [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the degree to which the 3-month course of methadone maintenance reduces illegal activities and improves employment and psychiatric symptoms [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Determine short term outcome after completion of methadone treatment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Obtain pilot data on the prevalence of hepatitis B and C among study patients [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: June 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
25 HIV negative opiate dependent patients all treated with methadone
Drug: Methadone
short-term methadone maintenance
Active Comparator: 2
25 HIV positive opiate dependent patients all treated with methadone
Drug: Methadone
short-term methadone maintenance

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351026

Locations
Ukraine
Kiev City AIDS Center
Kiev, 115, Ukraine, 03115
City AIDS Center
Kiev, Ukraine
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00351026     History of Changes
Other Study ID Numbers: R21 DA021073, R21DA021073, R21 DA021073
Study First Received: July 10, 2006
Last Updated: January 17, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
opioid dependence
methadone
HIV

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 11, 2014