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

May 27, 2015 updated by: Prof. Dr. med. Jens Reimer, Universitätsklinikum Hamburg-Eppendorf
Study objective: Feasibility and efficacy of a standardised psychosocial intervention (psychoeducation) in substituted opioid dependent patients

Study Overview

Status

Completed

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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-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.

NO_INTERVENTION: Treatment as usual
Control group did not received no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retention in antiviral treatment (feasibility)
Time Frame: within the first 24/48 weeks
within the first 24/48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Psychological health
Time Frame: within the first 24/48 weeks
within the first 24/48 weeks
Medical process on the basis of retention in substitution treatment
Time Frame: within the first 24/48 weeks
within the first 24/48 weeks
Permanent virus suppression
Time Frame: within the first 24/48 weeks
within the first 24/48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jörg Gölz, MD, Praxiszentrum Kaiserdamm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 13, 2009

First Posted (ESTIMATE)

February 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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