Chronic Hepatitis C, Intravenous Drug Abuse
Conditions
Keywords
Opiate Dependence, Chronic Hepatitis C
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).
Interventions
BEHAVIORALPsychoeducation
Group-therapeutic intervention with 12 sessions plus 5 update sessions with 24-week therapy duration and/or 12 sessions plus 10 update sessions with 48-week therapy duration Module I: Create understanding, resources, problems and solutions Module II: Information on hepatitis C infection Module III: Information on treatment Module IV: Specific information on depression and withdrawal symptoms under interferon The meetings take a minimum of 60 min. time, should be once weekly. The group size should lie between 6 and 12 participants. The group leaders are trained in performance of the psycho-education.
Sponsors
Hoffmann-La Roche
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retention in antiviral treatment (feasibility) | within the first 24/48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed