NCT00844272已完成4 期
Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 189
- 主要终点
- Retention in antiviral treatment (feasibility)
研究概览
简要总结
Study objective: Feasibility and efficacy of a standardised psychosocial intervention (psychoeducation) in substituted opioid dependent patients
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
结局指标
主要结局
Retention in antiviral treatment (feasibility)
时间窗: within the first 24/48 weeks
次要结局
- Psychological health(within the first 24/48 weeks)
- Medical process on the basis of retention in substitution treatment(within the first 24/48 weeks)
- Permanent virus suppression(within the first 24/48 weeks)
研究者
Prof. Dr. med. Jens Reimer
Director Centre for Interdisciplinäry Addiction Research
Universitätsklinikum Hamburg-Eppendorf
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