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

Primary Purpose

Intravenous Drug Abuse, Chronic Hepatitis C

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intravenous Drug Abuse focused on measuring Opiate Dependence, Chronic Hepatitis C

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Psychoeducation

    Treatment as usual

    Arm Description

    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

    Control group did not received no intervention.

    Outcomes

    Primary Outcome Measures

    Retention in antiviral treatment (feasibility)

    Secondary Outcome Measures

    Psychological health
    Medical process on the basis of retention in substitution treatment
    Permanent virus suppression

    Full Information

    First Posted
    February 12, 2009
    Last Updated
    May 27, 2015
    Sponsor
    Universitätsklinikum Hamburg-Eppendorf
    Collaborators
    Hoffmann-La Roche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00844272
    Brief Title
    Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment
    Acronym
    Permit
    Official Title
    Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    November 2008 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitätsklinikum Hamburg-Eppendorf
    Collaborators
    Hoffmann-La Roche

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intravenous Drug Abuse, Chronic Hepatitis C
    Keywords
    Opiate Dependence, Chronic Hepatitis C

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    189 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Psychoeducation
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Treatment as usual
    Arm Type
    No Intervention
    Arm Description
    Control group did not received no intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychoeducation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Retention in antiviral treatment (feasibility)
    Time Frame
    within the first 24/48 weeks
    Secondary Outcome Measure Information:
    Title
    Psychological health
    Time Frame
    within the first 24/48 weeks
    Title
    Medical process on the basis of retention in substitution treatment
    Time Frame
    within the first 24/48 weeks
    Title
    Permanent virus suppression
    Time Frame
    within the first 24/48 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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: Leukocytes ≥ 3.000/mm3 Neutrophile granulocytes ≥ 1.500/mm3 Thrombocytes ≥ 90.000/mm3 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) Albumin within the standard range 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jörg Gölz, MD
    Organizational Affiliation
    Praxiszentrum Kaiserdamm
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23884073
    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.
    Results Reference
    derived

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