- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00351026
Methadone Maintenance & HIV Risk in Ukraine
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Kiev, Ukraine, 03115
- Kiev City AIDS Center
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Kiev, Ukraine
- City AIDS Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
25 HIV negative opiate dependent patients all treated with methadone
|
short-term methadone maintenance
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Active Comparator: 2
25 HIV positive opiate dependent patients all treated with methadone
|
short-term methadone maintenance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months
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Measure the impact of a 3-month course of methadone treatment in HIV+ and HIV- on reducing opioid use
Time Frame: 3 months
|
3 months
|
Measure the impact of a 3-month course of methadone treatment in HIV+ and HIV- on reducing HIV risk behavior
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months
|
Determine short term outcome after completion of methadone treatment
Time Frame: 3 months
|
3 months
|
Obtain pilot data on the prevalence of hepatitis B and C among study patients
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Methadone
Other Study ID Numbers
- R21DA021073 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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