Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment

Phase 4

Completed

• Conditions: Chronic Hepatitis C; Intravenous Drug Abuse

• Registration Number: NCT00844272
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

Study objective: Feasibility and efficacy of a standardised psychosocial intervention (psychoeducation) in substituted opioid dependent patients

Detailed Description

Primary objective:

* Retention in antiviral treatment (feasibility)

Secondary objectives:

* Mental Health Mental health is monitored by means of the Symptom Checklist 90-R (SCL-90-R). Its sum score, the Global Severity Index (GSI), serves as indicator. Mental health will be regarded as stable in case of a change of less than 6 GSI-points, otherwise mental health will be regarded as improved (GSI - 6 points) or decreased (GSI + 6 points).

* Course of Addiction Course of addiction under antiviral treatment will be monitored according to retention in substitution treatment, compliance with scheduled visits, and co-consumption of illicit drugs (patients record, urinalysis).

* Sustained viral response (SVR) SVR as measured by polymerase chain reaction 6 months after per protocol antiviral treatment (ITT-analysis).

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2008-11
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Study Completion: 2009-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

• Women and men at the age of 18 to 70 years

• Opiate dependence according to ICD-10

• Stable substitution (i.e. either keeping the last 5 dates or fulfilling criteria for the Take Home assignment)

• Proof of HCV by means of PCR

• Patient must be therapy naive regarding the hepatitis C (no preceding treatment attempts with interferon and/or Ribavirin)

• Ability to comprehend und follow the study protocol

• Compensated liver disease with the following haematological and biochemical minimum criteria:

  1. Leukocytes ≥ 3.000/mm3
  2. Neutrophile granulocytes ≥ 1.500/mm3
  3. Thrombocytes ≥ 90.000/mm3
  4. Direct and indirect bilirubin within the standard range (if not factors, which are not hepatitis-conditioned, as M. Meulengracht, represent an explanation for the increase of the indirect bilirubin; in these cases the indirect bilirubin must be less than 3.0 mg/dl or 51.3 µmol/l)
  5. Albumin within the standard range
  6. Creatinine within the standard range

• TSH (Thyreotropine) within the standard range of the test laboratory

• Normal blood sugar value for non-diabetics or haemoglobin A1c max. 8.5% for diabetics (induced by pharmacotherapy and/or diet controls). An eye examination is required in diabetics.

• Haemoglobin values ≥ 12 mg/dl for women and/or ≥ 13 mg/dl for men

• ANA ≤ 1:160

• In patients with cirrhosis or transition to cirrhosis: exclusion of hepatocellular carcinoma

• Readiness to abstain from alcohol during interferon treatment.

• Negative pregnancy test in female patients within 24 hours before the first dose

• Regular confirmation that sexual active women at the age capable of child-bearing and/or sexual active men use two reliable methods of contraception during interferon / ribavirin treatment and six months thereafter, one contraception method with barrier effect (e.g. condom, diaphragm)

• Female patients may not breastfeed during interferon / ribavirin treatment.

Exclusion Criteria

• Decompensated liver cirrhosis (Child-Pugh B or C)
• Haemochromatosis
• Lack of Alfa-1-Antitrypsin (homozygote - PIZZ)
• Morbus-Wilson
• positive proof of HBsAg, anti- HIV or anti- HAV IgM antibodies
• Autoimmune diseases (e.g. autoimmune hepatitis, autoimmune thyroid disease, rheumatoid arthritis)
• Kidney failure (Creatinine > 1,5 mg/dl)
• Liver- or kidney-transplantation
• Hyperlipidemia (Cholesterol > 1,5-times above the upper standard value)
• Clinically manifested gout
• Severe heart insufficiency
• Severe coronary heart disease
• Patients with cardiac pacemaker
• Severe chronic pulmonary diseases (e.g. COPD)
• Serious psychological illness, in particular severe depression
• Epilepsy
• Oesophagus varicose in the prehistory
• Patient with high anaemia risk (e.g. Thalassaemia)
• Retinopathy
• Severe other illness
• Patients, who cannot follow the study conditions
• Male partners of pregnant women
• Current desire to have children / no safe contraception under therapy and until including 6 months after study end
• Participation in a clinical study within the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Retention in antiviral treatment (feasibility)	within the first 24/48 weeks

Secondary Outcome Measures

Name	Time	Method
Psychological health	within the first 24/48 weeks
Medical process on the basis of retention in substitution treatment	within the first 24/48 weeks
Permanent virus suppression	within the first 24/48 weeks