Psychoeducation Reaches HCV-Infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment (Permit)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was  Active, not recruiting
Hoffmann-La Roche
Information provided by:
Universitätsklinikum Hamburg-Eppendorf Identifier:
First received: February 12, 2009
Last updated: February 13, 2009
Last verified: February 2009

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

Condition Intervention Phase
Intravenous Drug Abuse
Chronic Hepatitis C
Behavioral: Psychoeducation
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychoeducation Reaches HCV-Infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment

Resource links provided by NLM:

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Retention in antiviral treatment (feasibility) [ Time Frame: within the first 24/48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychological health [ Time Frame: within the first 24/48 weeks ] [ Designated as safety issue: Yes ]
  • Medical process on the basis of retention in substitution treatment [ Time Frame: within the first 24/48 weeks ] [ Designated as safety issue: Yes ]
  • Permanent virus suppression [ Time Frame: within the first 24/48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: May 2005
Estimated Study Completion Date: September 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychoeducation 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.

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).

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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  More Information

No publications provided by Universitätsklinikum Hamburg-Eppendorf

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Jörg Gölz (Principal Investigator), Clinic Kaiserdamm Identifier: NCT00844272     History of Changes
Other Study ID Numbers: CIAR-PERMIT
Study First Received: February 12, 2009
Last Updated: February 13, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Opiate Dependence
Chronic Hepatitis C

Additional relevant MeSH terms:
Hepatitis C, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis C
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases processed this record on March 26, 2015