Clinical trial NCT00844272: Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment
Official title: Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intravenous Drug Abuse
Chronic Hepatitis C
Keywords: Opiate Dependence
Chronic Hepatitis C
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2009-02-16
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Retention in antiviral treatment (feasibility)
timeFrame: within the first 24/48 weeks
Secondary outcomes:
measure: Psychological health
timeFrame: within the first 24/48 weeks
measure: Medical process on the basis of retention in substitution treatment
timeFrame: within the first 24/48 weeks
measure: Permanent virus suppression
timeFrame: within the first 24/48 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Praxiszentrum Kaiserdamm
name: Jörg Gölz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reimer J, Schmidt CS, Schulte B, Gansefort D, Golz J, Gerken G, Scherbaum N, Verthein U, Backmund M. Psychoeducation improves hepatitis C virus treatment during opioid substitution therapy: a controlled, prospective multicenter trial. Clin Infect Dis. 2013 Aug;57 Suppl 2:S97-104. doi: 10.1093/cid/cit307.