Status:
COMPLETED
Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Intravenous Drug Abuse
Chronic Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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:
- Leukocytes ≥ 3.000/mm3
- Neutrophile granulocytes ≥ 1.500/mm3
- Thrombocytes ≥ 90.000/mm3
- 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)
- Albumin within the standard range
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT00844272
Start Date
May 1 2005
End Date
November 1 2009
Last Update
May 28 2015
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