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

NCT ID: NCT00844272

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2009-11-30

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).

Conditions

Intravenous Drug Abuse; Chronic Hepatitis C

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Psychoeducation

Intervention Type: BEHAVIORAL

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.

Treatment as usual

Control group did not received no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Psychoeducation

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Jens Reimer

Director Centre for Interdisciplinäry Addiction Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jörg Gölz, MD

Role: PRINCIPAL_INVESTIGATOR

Praxiszentrum Kaiserdamm

References

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.

Reference Type: DERIVED

PMID: 23884073 (View on PubMed)

Other Identifiers

CIAR-PERMIT

Identifier Type: -

Identifier Source: org_study_id