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

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

Detailed Description
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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).

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

Conditions
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Intravenous Drug Abuse, Chronic Hepatitis C

Intervention / Treatment
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* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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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: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychoeducation<br>PE group sessions lasted 60 minutes and were carried out under continuous supervision. The manualised program was especially tailored to (former) IDUs in HCV treatment, containing the following aspects: Module 1: HCV infection and symptoms, course of illness, interaction with opioid dependence, further problems and risk factors Module 2: HCV treatment, side effects, psychiatric and somatic comorbidities, reinfection and drug use, risk behaviour Module 3: Coping strategies, resources and self-help, effective use of health-care support, the role of social environment, healthy living & nutrition | Behavioral: Psychoeducation<br>* 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.<br>|
| No Intervention: Treatment as usual<br>Control group did not received no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in antiviral treatment (feasibility) |  | within the first 24/48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opiate Dependence, Chronic Hepatitis C