Hepatitis CPhase 4NCT00148031
Improving Hepatitis C Treatment in Injection Drug Users
A Phase 4 study testing Pegylated Interferon and Ribavirin, Psychosocial and On-site (MMT Clinic) HCV evaluation and treatment in people with Hepatitis C and Liver Diseases, run by State University of New York - Upstate Medical University at 2 sites in United States.
Trial summary
The overall goal of the research project is to improve the outcome of medical care for injection drug users (IDUs) with Hepatitis C viral (HCV) infection. Hypothesis: An intervention designed to improve the rate of HCV treatment completion and sustained virologic response (SVR) in IDUs will increase access by… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Liver Diseases, Drug Abuse
- What is being tested?
- Pegylated Interferon and Ribavirin, Psychosocial and On-site (MMT Clinic) HCV evaluation and treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2003to Mar 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age.
- Enrolled in outpatient methadone maintenance treatment for greater than 3 months.
- Hepatitis C RNA positive.
- Willingness to accept HCV treatment.
- Subject has non-VA (Veteran's Administration) medical insurance or is willing to bear any and all expenses associated with Hepatitis C medical treatment.
Who cannot join
- In need of inpatient drug or alcohol detoxification.
- Currently receiving the standard Hepatitis C treatment
- Unable to give adequate informed consent.
- Pregnant, nursing, or planning to become pregnant during HCV treatment or within 6 months following completion of treatment.
- Male subject who has a female sexual partner who is pregnant or planning to become pregnant at any time during HCV treatment or within 6 months following completion of treatment.
- Female subject or male subject who has a female sexual partner who is of child bearing years and not using two medically approved forms of contraception.
Show all 9Show fewer
- Subject has made a commitment to attend residential care psychiatric or drug/alcohol rehabilitation, which would lead to unavailability to attend regularly scheduled medical care and research visits.
- Subject did not attend all required screening appointments.
- Subject has a legal proceeding whose outcome may lead to incarceration within 3 months of intake.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Crouse Chemical Dependency Treatment Services
Syracuse, New York, 13210
SUNY Upstate Medical University - Department of Gastroenterology
Syracuse, New York, 13210
About this study
The overall goal of the research project is to improve the outcome of medical care for injection drug users (IDUs) with Hepatitis C viral (HCV) infection.
Hypothesis: An intervention designed to improve the rate of HCV treatment completion and sustained virologic response (SVR) in IDUs will increase access by integrating HCV medical care into a substance abuse treatment program.
Read the detailed description
The overall goal of the proposed health services research project is to improve the outcome of medical care for injection drug users (IDUs) with Hepatitis C viral (HCV) infection. This will be done by testing an intervention designed to improve the rate of HCV treatment completion and sustained virologic response (SVR) in IDUs. This intervention will increase access by integrating HCV medical care into a substance abuse treatment program. HCV infection is endemic among IDUs, and is associated with significant medical morbidity. While antiviral treatments are improving rapidly, providing HCV medical care for IDUs remains problematic for a number of reasons. IDUs often do not have adequate access to HCV diagnosis and treatment services, and they may have co-morbid psychiatric diagnoses that affect the ability to withstand the demands of HCV treatment. Therefore, this study will also examine psychiatric disorders and psychiatric symptoms in IDUs who are infected with Hepatitis C virus.
The proposed project is a five-year program consisting of a controlled clinical trial, studying 220 patients with HCV infection enrolled in methadone maintenance treatment (MMT). The HCV Medical Care Study is a randomized trial to test the efficacy of On-site HCV Medical Care provided at the MMT program versus Off-site care at the Gastroenterology (GI) Clinic. HCV antibody positive MMT patients (N=220) will be randomly assigned to receive HCV medical services either through an integrated delivery model located on-site in the MMT clinic, or through usual off-site referral to the GI Clinic. The main outcomes will be the rates of attaining SVR and completion of HCV treatment, as well as other measures of HCV-related health outcomes and quality of life. Participants will be evaluated for Axis I psychiatric diagnoses and will complete psychiatric measures at monthly intervals throughout the study. Psychiatric diagnosis will be made using the Structured Psychiatric Interview for the DSM-IV (SCID) and psychiatric symptom severity will be assessed for depression, mania, anxiety, and psychosis. Drug use measures, and quality of life measures will also be obtained. These data are expected to yield new knowledge about the efficacy of providing on-site HVC medical care in substance abuse treatment programs. They will provide a comparison of psychiatric diagnoses and psychiatric symptom presentation in HCV positive IDUs who choose to receive HCV treatment and those who do not choose to follow through with HCV treatment and will describe changes in psychiatric symptoms before, during, and after HCV medical care. Finally, the studies will also provide information about the influence of psychiatric symptoms and drug and alcohol use on HCV medical outcomes such as treatment completion and SVR.
- Conditions
- Hepatitis C, Liver Diseases, Drug Abuse, Alcoholism
- Being tested
- Pegylated Interferon and Ribavirin, Psychosocial, On-site (MMT Clinic) HCV evaluation and treatment, Off-site HCV evaluation and treatment
- Keywords
- behavior modification, health care service utilization, hepatitis C,, injection drug use, therapy compliance, alcoholism, alcohol abuse, prevention, drug abuse, liver disorder, HCV, methadone
- Medical subject headings
- Hepatitis C, Liver Diseases, Substance-Related Disorders, Alcoholism, Patient Acceptance of Health Care, Patient Compliance, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Interferon and RibavirinDrug
Both groups with receive the same medical intervention but offered at different locations
PsychosocialBehavioural
Assessment of the likelihood of HCV treatment initiation and completion
On-site (MMT Clinic) HCV evaluation and treatmentBehavioural
Standard HCV treatment with Pegylated Interferon and Ribavirin
Off-site HCV evaluation and treatmentBehavioural
Standard HCV treatment with Pegylated Interferon and Ribavirin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | On-site (MMT Clinic) HCV evaluation and treatment Receives: Drug: Pegylated Interferon and Ribavirin; Behavioral: Psychosocial; Behavioral: On-site (MMT Clinic) HCV evaluation and treatment |
| 2 | Active comparator | Off-site (GI Clinic) HCV evaluation and treatment Receives: Drug: Pegylated Interferon and Ribavirin; Behavioral: Psychosocial; Behavioral: Off-site HCV evaluation and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of On-site versus Off-site delivery of HCV medical care for methadone maintenance treatment (MMT) patients, as evaluated by the proportion of patients achieving sustained virological response (SVR).
Measured: 5 years
Secondary outcomes (1)
psychiatric diagnoses and symptom severity
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Batki, M.D., State University of New York - Upstate Medical University
- Investigators
- Steven L Batki, MD, Principal investigator, State University of New York, Upstate Medical University - Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148031
- Sponsor's protocol ID
- SUNY UMU IRB # 4929
- Other IDs
- R01DA016764
- Status last verified
- Apr 2013
- First submitted
- 2 Sep 2005
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cornell, M.E., Peek, R.M.H., Batki, S.L. (2002) Hepatitis C in an Upstate New York methadone treatment population: Preliminary analysis. Drug and Alcohol Dependence 66:S36-37.
Batki, S.L., Srinath, A.K., Cornell, M.E., Bowman, M., Peek, R.M.H., Wade, M., Dimmock, J., Abdul-Hamid, M. (2005) Depression and Substance Use in Methadone Patients with Hepatitis C. American Journal on Addictions 14:304-5.
Batki, S.L., Canfield, K.M., Cole, C., Smyth, E., Pham, H., Ploutz-Snyder, R.; Amodio, K., Manser, K., Knoeller, G., Strutynski, K., Levine, R., Dimmock J.A. (2007) (abstract) Psychiatric diagnosis and psychiatric symptom severity in methadone treatment patients with untreated hepatitis C virus infection. American Journal on Addictions, 16:316-17.
Batki, S.L., Canfield, K., Lundell, S., Levine, R., Donohue, L., Amodio, K. (oral presentation) Characteristics of opioid-dependent patients seeking Hepatitis C treatment. College on the Problems of Drug Dependence, Orlando, June.
Batki, S.L., Canfield, K.M., Cole, C., Ploutz-Snyder, R., Dimmock, J., Pham, H., Smythe, E. (oral presentation) Quality of life in MMT patients with untreated HCV infection. College on the Problems of Drug Dependence, Scottsdale, June 2006.
Batki, S.L.; Canfield, K.; Cole, C.; Smyth, E.; Ploutz-Snyder, R.; Levine, R.; Amodio, K.; Knoeller, G.; Strutynski, K.; Manser, K.; Dimmock, J.A. (oral presentation) Hepatitis C treatment progress by methadone maintenance patients: Preliminary analysis of a trial of co-located treatment. College on the Problems of Drug Dependence, Quebec City, June 2007
Batki, S.L., Canfield, K.M., Smyth, E., Amodio, K., Manser, K., Levine, R.A. (poster presentation) Effects of medical and psychiatric comorbidity on HCV treatment eligibility in methadone maintenance. College on the Problems of Drug Dependence, Annual Meeting, San Juan, Puerto Rico June, 2008
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Hepatitis C Treatment in Injection Drug Users
- ClinicalTrials.gov ID
- NCT00148031
- Acronym / sponsor ID
- SUNY UMU IRB # 4929
- Conditions
- Hepatitis C, Liver Diseases, Drug Abuse, Alcoholism
- Keywords
- behavior modification, health care service utilization, hepatitis C,, injection drug use, therapy compliance, alcoholism, alcohol abuse, prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 7 Sep 2005 (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 overall goal of the research project is to improve the outcome of medical care for injection drug users (IDUs) with Hepatitis C viral (HCV) infection.
Hypothesis: An intervention designed to improve the rate of HCV treatment completion and sustained virologic response (SVR) in IDUs will increase access by integrating HCV medical care into a substance abuse treatment program.
Detailed description
The overall goal of the proposed health services research project is to improve the outcome of medical care for injection drug users (IDUs) with Hepatitis C viral (HCV) infection. This will be done by testing an intervention designed to improve the rate of HCV treatment completion and sustained virologic response (SVR) in IDUs. This intervention will increase access by integrating HCV medical care into a substance abuse treatment program. HCV infection is endemic among IDUs, and is associated with significant medical morbidity. While antiviral treatments are improving rapidly, providing HCV medical care for IDUs remains problematic for a number of reasons. IDUs often do not have adequate access to HCV diagnosis and treatment services, and they may have co-morbid psychiatric diagnoses that affect the ability to withstand the demands of HCV treatment. Therefore, this study will also examine psychiatric disorders and psychiatric symptoms in IDUs who are infected with Hepatitis C virus.
The proposed project is a five-year program consisting of a controlled clinical trial, studying 220 patients with HCV infection enrolled in methadone maintenance treatment (MMT). The HCV Medical Care Study is a randomized trial to test the efficacy of On-site HCV Medical Care provided at the MMT program versus Off-site care at the Gastroenterology (GI) Clinic. HCV antibody positive MMT patients (N=220) will be randomly assigned to receive HCV medical services either through an integrated delivery model located on-site in the MMT clinic, or through usual off-site referral to the GI Clinic. The main outcomes will be the rates of attaining SVR and completion of HCV treatment, as well as other measures of HCV-related health outcomes and quality of life. Participants will be evaluated for Axis I psychiatric diagnoses and will complete psychiatric measures at monthly intervals throughout the study. Psychiatric diagnosis will be made using the Structured Psychiatric Interview for the DSM-IV (SCID) and psychiatric symptom severity will be assessed for depression, mania, anxiety, and psychosis. Drug use measures, and quality of life measures will also be obtained. These data are expected to yield new knowledge about the efficacy of providing on-site HVC medical care in substance abuse treatment programs. They will provide a comparison of psychiatric diagnoses and psychiatric symptom presentation in HCV positive IDUs who choose to receive HCV treatment and those who do not choose to follow through with HCV treatment and will describe changes in psychiatric symptoms before, during, and after HCV medical care. Finally, the studies will also provide information about the influence of psychiatric symptoms and drug and alcohol use on HCV medical outcomes such as treatment completion and SVR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pegylated Interferon and Ribavirin, Behavioral: Psychosocial, Behavioral: On-site (MMT Clinic) HCV evaluation and treatmentOn-site (MMT Clinic) HCV evaluation and treatment |
| 2 | Active comparator | Drug: Pegylated Interferon and Ribavirin, Behavioral: Psychosocial, Behavioral: Off-site HCV evaluation and treatmentOff-site (GI Clinic) HCV evaluation and treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years of age.
- Enrolled in outpatient methadone maintenance treatment for greater than 3 months.
- Hepatitis C RNA positive.
- Willingness to accept HCV treatment.
- Subject has non-VA (Veteran's Administration) medical insurance or is willing to bear any and all expenses associated with Hepatitis C medical treatment.
Key exclusion criteria (9 listed)
- In need of inpatient drug or alcohol detoxification.
- Currently receiving the standard Hepatitis C treatment
- Unable to give adequate informed consent.
- Pregnant, nursing, or planning to become pregnant during HCV treatment or within 6 months following completion of treatment.
- Male subject who has a female sexual partner who is pregnant or planning to become pregnant at any time during HCV treatment or within 6 months following completion of treatment.
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 |
|---|---|---|
| Pegylated Interferon and RibavirinBoth groups with receive the same medical intervention but offered at different locations | Drug | 1, 2 |
| PsychosocialAssessment of the likelihood of HCV treatment initiation and completion | Behavioural | 1, 2 |
| On-site (MMT Clinic) HCV evaluation and treatmentStandard HCV treatment with Pegylated Interferon and Ribavirin | Behavioural | 1 |
| Off-site HCV evaluation and treatmentStandard HCV treatment with Pegylated Interferon and Ribavirin | Behavioural | 2 |
Primary outcome
Efficacy of On-site versus Off-site delivery of HCV medical care for methadone maintenance treatment (MMT) patients, as evaluated by the proportion of patients achieving sustained virological response (SVR).
Time frame: 5 years
1 secondary outcome
psychiatric diagnoses and symptom severity
Time frame: 5 years
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 24 Apr 2013.
- BackgroundCornell, M.E., Peek, R.M.H., Batki, S.L. (2002) Hepatitis C in an Upstate New York methadone treatment population: Preliminary analysis. Drug and Alcohol Dependence 66:S36-37.
- BackgroundBatki, S.L., Srinath, A.K., Cornell, M.E., Bowman, M., Peek, R.M.H., Wade, M., Dimmock, J., Abdul-Hamid, M. (2005) Depression and Substance Use in Methadone Patients with Hepatitis C. American Journal on Addictions 14:304-5.
- Results publicationBatki, S.L., Canfield, K.M., Cole, C., Smyth, E., Pham, H., Ploutz-Snyder, R.; Amodio, K., Manser, K., Knoeller, G., Strutynski, K., Levine, R., Dimmock J.A. (2007) (abstract) Psychiatric diagnosis and psychiatric symptom severity in methadone treatment patients with untreated hepatitis C virus infection. American Journal on Addictions, 16:316-17.
- Results publicationBatki, S.L., Canfield, K., Lundell, S., Levine, R., Donohue, L., Amodio, K. (oral presentation) Characteristics of opioid-dependent patients seeking Hepatitis C treatment. College on the Problems of Drug Dependence, Orlando, June.
- Results publicationBatki, S.L., Canfield, K.M., Cole, C., Ploutz-Snyder, R., Dimmock, J., Pham, H., Smythe, E. (oral presentation) Quality of life in MMT patients with untreated HCV infection. College on the Problems of Drug Dependence, Scottsdale, June 2006.
- Results publicationBatki, S.L.; Canfield, K.; Cole, C.; Smyth, E.; Ploutz-Snyder, R.; Levine, R.; Amodio, K.; Knoeller, G.; Strutynski, K.; Manser, K.; Dimmock, J.A. (oral presentation) Hepatitis C treatment progress by methadone maintenance patients: Preliminary analysis of a trial of co-located treatment. College on the Problems of Drug Dependence, Quebec City, June 2007
- Results publicationBatki, S.L., Canfield, K.M., Smyth, E., Amodio, K., Manser, K., Levine, R.A. (poster presentation) Effects of medical and psychiatric comorbidity on HCV treatment eligibility in methadone maintenance. College on the Problems of Drug Dependence, Annual Meeting, San Juan, Puerto Rico June, 2008
- State University of New York, Upstate Medical UniversityLink provided by the sponsor.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
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.
Steven L Batki, MD principal investigator
State University of New York, Upstate Medical University - Department of Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegylated Interferon and Ribavirin, Psychosocial and On-site (MMT Clinic) HCV evaluation and treatment in people with Hepatitis C and Liver Diseases, run by State University of New York - Upstate Medical University at 2 sites 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 9 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 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Efficacy of On-site versus Off-site delivery of HCV medical care for methadone maintenance treatment (MMT) patients, as evaluated by the proportion of patients achieving sustained virological response (SVR). (time frame: 5 years). 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 NCT00148031, which also lists 7 linked publications.
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 24 Apr 2013.