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

February 12, 2009
February 13, 2009
May 2005
November 2008   (final data collection date for primary outcome measure)
Retention in antiviral treatment (feasibility) [ Time Frame: within the first 24/48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00844272 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Psychoeducation Reaches HCV-Infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment
Psychoeducation Reaches HCV-Infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment

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

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).
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Intravenous Drug Abuse
  • Chronic Hepatitis C
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.

Experimental: Psychoeducation
Intervention: Behavioral: Psychoeducation
Reimer J, Schmidt CS, Schulte B, Gansefort D, Gölz 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
September 2009
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00844272
CIAR-PERMIT
Yes
Dr. Jörg Gölz (Principal Investigator), Clinic Kaiserdamm
Universitätsklinikum Hamburg-Eppendorf
Hoffmann-La Roche
Not Provided
Universitätsklinikum Hamburg-Eppendorf
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP