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Completed

NCT Number: NCT00147784

HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group.

* 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

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Key information

Conditions

Opiate Dependence Chemically-Induced Disorders Digestive System Diseases Hepatitis Liver Diseases Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Addiction Unit, Sorlandet Hospital, Kristiansand, Vest-Agder, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Serologic evidence of hepatitis C infection, genotype 2 and 3
  • Normal or elevated serum ALT activity
  • In MMT-programme and with at least 6 months with satisfactory drug abuse control. That means no iv injections and no or minimal use of drugs.
  • Male and female patients

Exclusion criteria

  • Women with ongoing pregnancy or breast feeding
  • Untreated serious psychiatric disorders, particularly depression.
  • Serious drug abuse or alcohol abuse last 6 months
  • Intravenous drug abuse last 6 months
  • Hepatitis A, B or HIV infection
  • HCV genotype 1, 4, 5 and 6
  • Leucocytes < 3000 cells/mm3 at screening (neutrophil count <1500 cells/mm3)
  • Platelet count < 80 000 cells/mm3 at screening
  • Hb <11 g/dL in women or <12 g/dL in men at screening
  • Documented or presumed coronary artery disease or cerebrovascular disease
  • Thyroid dysfunction not adequately controlled
  • Epilepsy
  • Malignant disease

Treatment and study plan

Ribavirin

Drug

800 mg pr. os daily, 400 mg morning and 400 mg evening (200 mg/tbl.) for 14 weeks

Pegylated interferon

Drug

180 mikrogram in 0,5 ml solution s.c. once a week for 14 weeks

Primary outcomes

  1. - 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Official study title

HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a Methadone Maintenance Treated (MMT) Opioid Addicted Group.

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Sep 7, 2005
Registry last updated
Mar 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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