Bridging Active Heroin Users to Hepatitis C Treatment Using Buprenorphine - 1
This trial has been completed.
|Conditions||hepatitis c, heroin dependence|
|Sponsor||National Institute on Drug Abuse (NIDA)|
|Collaborator||Organization to Achieve Solutions in Substance Abuse (OASIS)|
|Start date||June 2003|
|End date||March 2004|
|Trial size||10 participants|
|Trial identifier||NCT00249574, NIDA-15629-1, R01-15629-1|
The purpose of this study is to see whether street-recruited heroin users can be successfully treated for hepatitis C after stabilizing them on buprenorphine.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Effectiveness of medication
All participants from 18 years up to 80 years old.
Inclusion Criteria: - Active heroin or other illicit opioid use - Active hepatitis C - No medical or psychiatric contraindications - Able to sign informed consent Exclusion Criteria: - No opiate dependence - Age <18 - Unable or uninterested in attending weekly group sessions
|Official title||HCV Treatment of IDUs After Buprenorphine Stabilization|
|Principal investigator||Diana L Sylvestre, M.D.|
|Description||This is a prospective pilot safety study based on the hypothesis that active, street-recruited heroin users can be successfully treated for hepatitis C after stabilization on buprenorphine. Eligible subjects will be actively using heroin and have hepatitis C viremia; screening will occur at street-based sites like syringe exchange programs. Those who are eligible will sign informed consent, and then be asked to attend 3 weekly educational sessions about hepatitis C and addiction as well as undergo an intake interview. After this, subjects will be inducted onto buprenorphine/naloxone combination therapy (Suboxone) and receive this medication for 12-24 weeks. Once reaching the 12-24 week study time point, subjects will have the option of a 12-week Suboxone taper, or instead of undergoing 6-12 months of hepatitis C treatment with pegylated interferon and ribavirin while being maintained on Suboxone. Once completing hepatitis C treatment, subjects will undergo a 24-week Suboxone taper, or be transitioned to outpatient Suboxone therapy by a medical provider.|
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