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

NCT00844272 | Completed Phase 4 DMC

• 1 other identifier: CIAR-PERMIT
• Study Type: interventional
• Target: 189
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Intravenous Drug Abuse; Chronic Hepatitis C

Keywords

Opiate Dependence; Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Retention in antiviral treatment (feasibility)

  within the first 24/48 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Psychoeducation

EXPERIMENTAL

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

Behavioral: Psychoeducation

Treatment as usual

NO INTERVENTION

Control group did not received no intervention.

Interventions

Psychoeducation BEHAVIORAL

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.

Psychoeducation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Hoffmann-La Roche: collaborator

Related Publications (1)

• Reimer J, Schmidt CS, Schulte B, Gansefort D, Golz 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.

  PMID: 23884073 DERIVED

MeSH Terms

Conditions

Substance Abuse, Intravenous; Hepatitis C, Chronic; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders

Study Officials

• Jörg Gölz, MD

  Praxiszentrum Kaiserdamm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Centre for Interdisciplinäry Addiction Research

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 16, 2009
• Study Start: May 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2009
• Last Updated: May 28, 2015

Record last verified: 2015-05