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
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00844272
First received: February 12, 2009
Last updated: February 13, 2009
Last verified: February 2009
  Purpose

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).
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Universitätsklinikum Hamburg-Eppendorf

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Jörg Gölz (Principal Investigator), Clinic Kaiserdamm
ClinicalTrials.gov 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
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Substance Abuse, Intravenous
Chemically-Induced Disorders
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Mental Disorders
RNA Virus Infections
Substance-Related Disorders
Virus Diseases
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014