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

Phase 4

Completed

• Conditions: Chronic Hepatitis C; Intravenous Drug Abuse
• Interventions: Behavioral: Psychoeducation

• 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

Arm && Interventions

Group	Intervention	Description
Psychoeducation	Psychoeducation	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

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