- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00844272
Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment (Permit)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- 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
Study Plan
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:
|
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
Collaborators
Investigators
- Principal Investigator: Jörg Gölz, MD, Praxiszentrum Kaiserdamm
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Substance-Related Disorders
- Substance Abuse, Intravenous
- Hepatitis
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
Other Study ID Numbers
- CIAR-PERMIT
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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