HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group.
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|ClinicalTrials.gov Identifier: NCT00147784|
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : March 28, 2008
- To evaluate if weekly psychological follow-up make opioid dependent patients in MMT able to accomplish 14 weeks treatment with Peginterferon alfa-2a (PEG-INF) and ribavirin to the same extent than non-opioid dependents.
- To determine the efficacy of this anti-HCV treatment
|Condition or disease||Intervention/treatment||Phase|
|Opiate Dependence Hepatitis||Drug: Ribavirin Drug: Pegylated Interferon||Phase 3|
Chronic infection with the hepatitis C virus (HCV) is a health problem worldwide. In Norway, there are about 3000 patients participating in Methadone Maintenance Treatment(MMT) programs. A prevalence study at the MMT treatment unit in Kristiansand, showed that more than 90 % of 177 patients have been infected with hepatitis C.
A major problem with anti-HCV treatment for this group is the lack of compliance and retention in treatment. Further, due to the high incidence of psychological disorders in opioid dependent patients, this may also complicate anti-HCV treatment. Drug addicted in MMT treatments programs may find themselves excluded from Hepatitis C treatment.
Due to better treatment efficacy with the new PEG-INF's and encouraging reports from 14 weeks studies, it may be easier to motivate opioid dependents to fulfill treatment. Weekly psychological follow-up of these patients will further increase the possibility of opioid dependents in MMT to be able to complete anti-HCV treatment.
The aim of this study is to focus on this patients situation, and strengthen their possibility to have a real opportunity to get treatment. We therefore wish to make a pilot study to investigate the feasibility, efficacy and psycological side-effects of the treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a Methadone Maintenance Treated (MMT) Opioid Addicted Group.|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||January 2008|
- Drug: Ribavirin
800 mg pr. os daily, 400 mg morning and 400 mg evening (200 mg/tbl.) for 14 weeks
- Drug: Pegylated Interferon
180 mikrogram in 0,5 ml solution s.c. once a week for 14 weeks
- - Percent of patients with sustained virological response, defined as undetectable HCV RNA 24 weeks after end of treatment [ Time Frame: 24 weeks after end of treatment ]
- Retention in treatment, compliance, psychological distress, measures of quality of life, perceived drug use control and urine toxicology [ Time Frame: 2, 4, 8, 14 and 24 weeks after study start ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147784
|Soerlandet Hospital HF|
|Kristiansand, Vest-Agder, Norway, 4604|
|Addiction Unit, Sorlandet Hospital|
|Kristiansand, Vest-Agder, Norway, N-4604|
|Principal Investigator:||Oistein Kristensen, MD||Soerlandet Hospital HF|
|Principal Investigator:||Oistein Kristensen, MD||Addiction Unit, SSHF|