Hepatitis CNCT00407732
Overcoming Psychiatric Barriers to the Treatment of Hepatitis C
A study testing psychosocial intervention in people with Hepatitis C and Substance Use Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate candidates for interferon therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Substance Use Disorders, Mental Disorder
- What is being tested?
- psychosocial intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Oct 2011
- Phase
- Interventional
- 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
- Patient has confirmed diagnosis of HCV;
- Patient has expressed an interest in undergoing interferon treatment;
- Patient is deferred from interferon therapy for psychiatric, alcohol use, or other psychosocial issues;
- Patient must be completely medically cleared by the hepatologist with no outstanding medical conditions that would deem them ineligible from treatment;
- Patient must have only psychiatric issues and/or substance use issues; but otherwise no other contraindications for treatment.
Who cannot join
- Patient has a diagnosis of schizophrenia, psychosis;
- Patient resides in a psychiatric residential facility;
- Patient attempted suicide in the past five years;
- Patient is a current intravenous drug user;
- Patient is cognitively or decisionally-impaired due to brain disease or injury;
- Patient has advanced liver disease that precludes them from interferon treatment;
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- Patient has other medical comorbidities that may exclude them from interferon treatment;
- Patient does not want to pursue interferon treatment at the present time;
- Patient has significant financial constraints, such as no insurance or homelessness, that would prevent them acquiring mental health or substance abuse services;
- No access to telephone service;
- Non-English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Overcoming Neuropsychiatric Barriers to the Treatment of Hepatitis C
The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate candidates for interferon therapy.
Read the detailed description
The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate candidates for interferon therapy. Patients who have been deferred from therapy due to mental health or substance abuse issues will work with the team psychologist on following through with the hepatologist's treatment recommendations that would lead to becoming eligible for interferon therapy.
- Conditions
- Hepatitis C, Substance Use Disorders, Mental Disorder
- Being tested
- psychosocial intervention
- Keywords
- hepatitis C, mental disorder, substance use, psychosocial intervention
- Medical subject headings
- Hepatitis C, Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocial interventionBehavioural
motivational enhancing case management intervention
| Study group | Role | What they receive |
|---|---|---|
| SC | No intervention | standard care |
| INT | Experimental | psychosocial intervention Receives: Behavioral: psychosocial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether or not the patient is deemed an appropriate candidate for interferon therapy at the end of the 9-month intervention.
Measured: 3-, 6-, and 9-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionFeb 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Donna Evon, University of North Carolina, Chapel Hill
- Investigators
- Donna M Evon, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407732
- Sponsor's protocol ID
- 05-2944 PEG228
- Status last verified
- Jan 2012
- First submitted
- 4 Dec 2006
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Neuropsychiatric Barriers to the Treatment of Hepatitis C
- ClinicalTrials.gov ID
- NCT00407732
- Acronym / sponsor ID
- 05-2944 PEG228
- Conditions
- Hepatitis C, Substance Use Disorders, Mental Disorder
- Keywords
- hepatitis C, mental disorder, substance use, psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jan 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 5 Dec 2006 (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.
The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate candidates for interferon therapy.
Detailed description
The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate candidates for interferon therapy. Patients who have been deferred from therapy due to mental health or substance abuse issues will work with the team psychologist on following through with the hepatologist's treatment recommendations that would lead to becoming eligible for interferon therapy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SC | No intervention | –standard care |
| INT | Experimental | Behavioral: psychosocial interventionpsychosocial intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient has confirmed diagnosis of HCV;
- Patient has expressed an interest in undergoing interferon treatment;
- Patient is deferred from interferon therapy for psychiatric, alcohol use, or other psychosocial issues;
- Patient must be completely medically cleared by the hepatologist with no outstanding medical conditions that would deem them ineligible from treatment;
- Patient must have only psychiatric issues and/or substance use issues; but otherwise no other contraindications for treatment.
Key exclusion criteria (11 listed)
- Patient has a diagnosis of schizophrenia, psychosis;
- Patient resides in a psychiatric residential facility;
- Patient attempted suicide in the past five years;
- Patient is a current intravenous drug user;
- Patient is cognitively or decisionally-impaired due to brain disease or injury;
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 |
|---|---|---|
| psychosocial interventionmotivational enhancing case management intervention | Behavioural | INT |
Primary outcome
Whether or not the patient is deemed an appropriate candidate for interferon therapy at the end of the 9-month intervention.
Time frame: 3-, 6-, and 9-months
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 25 Jan 2012.
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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.
Donna M Evon, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychosocial intervention in people with Hepatitis C and Substance Use Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 5 inclusion and 11 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 25 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Whether or not the patient is deemed an appropriate candidate for interferon therapy at the end of the 9-month intervention. (time frame: 3-, 6-, and 9-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2012.