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

Chronic Hepatitis C Clinical Trial

— Permit  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844272
• Other study ID #: CIAR-PERMIT
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2009
• Last updated: May 27, 2015
• Start date: May 2005
• Est. completion date: November 2009

Study information

• Verified date: May 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: November 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Intravenous Drug Abuse
• Substance Abuse, Intravenous

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in antiviral treatment (feasibility)		within the first 24/48 weeks	No
Secondary	Psychological health		within the first 24/48 weeks	Yes
Secondary	Medical process on the basis of retention in substitution treatment		within the first 24/48 weeks	Yes
Secondary	Permanent virus suppression		within the first 24/48 weeks	Yes