Intravenous Drug AbusePhase 4PermitNCT00844272
Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment
A Phase 4 study testing Psychoeducation in people with Intravenous Drug Abuse and Chronic Hepatitis C, run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
Study objective: Feasibility and efficacy of a standardised psychosocial intervention (psychoeducation) in substituted opioid dependent patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intravenous Drug Abuse, Chronic Hepatitis C
- What is being tested?
- Psychoeducation
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Nov 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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
About this study
Study objective: Feasibility and efficacy of a standardised psychosocial intervention (psychoeducation) in substituted opioid dependent patients
Read the 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).
- Conditions
- Intravenous Drug Abuse, Chronic Hepatitis C
- Being tested
- Psychoeducation
- Keywords
- Opiate Dependence, Chronic Hepatitis C
- Medical subject headings
- Substance Abuse, Intravenous, Hepatitis C, Chronic, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Psychoeducation |
| Treatment as usual | No intervention | Control group did not received no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in antiviral treatment (feasibility)
Measured: within the first 24/48 weeks
Secondary outcomes (3)
Psychological health
Measured: within the first 24/48 weeks
Medical process on the basis of retention in substitution treatment
Measured: within the first 24/48 weeks
Permanent virus suppression
Measured: within the first 24/48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startMay 2005
- Primary completionNov 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intravenous Drug AbuseStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Principal investigator, Prof. Dr. med. Jens Reimer, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Jörg Gölz, MD, Principal investigator, Praxiszentrum Kaiserdamm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844272
- Sponsor's protocol ID
- CIAR-PERMIT
- Acronym
- Permit
- Status last verified
- May 2015
- First submitted
- 12 Feb 2009
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23884073
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment
- ClinicalTrials.gov ID
- NCT00844272
- Acronym / sponsor ID
- Permit / CIAR-PERMIT
- Conditions
- Intravenous Drug Abuse, Chronic Hepatitis C
- Keywords
- Opiate Dependence, Chronic Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- May 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study objective: Feasibility and efficacy of a standardised psychosocial intervention (psychoeducation) in substituted opioid dependent patients
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Experimental | Behavioral: PsychoeducationPE 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 |
| Treatment as usual | No intervention | –Control group did not received no intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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)
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoeducationGroup-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. | Behavioural | Psychoeducation |
Primary outcome
Retention in antiviral treatment (feasibility)
Time frame: within the first 24/48 weeks
3 secondary outcomes
Psychological health
Time frame: within the first 24/48 weeks
Medical process on the basis of retention in substitution treatment
Time frame: within the first 24/48 weeks
Permanent virus suppression
Time frame: within the first 24/48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 23884073Reimer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Gölz, MD principal investigator
Praxiszentrum Kaiserdamm
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Psychoeducation in people with Intravenous Drug Abuse and Chronic Hepatitis C, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in antiviral treatment (feasibility) (time frame: within the first 24/48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00844272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.