Hepatitis CNCT01625793
Inflammation, Stress & Social Behavior: Using Ecological Assessments & Model Systems to Enhance Relevance to Health Outcomes
A study testing Interferon-alpha in people with Hepatitis C, run by University of Arizona at 2 sites in United States.
Trial summary
The current study has been designed to identify behavioral and physiological mechanisms through which positive social connectivity (PCS) and negative social processes (NSP) interact with psychosocial stress to promote resilience in the context of illness. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Interferon-alpha
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Jul 2013
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-65 years including males, females and minorities
- Ability to speak and read remedial English
- Serum positive for either anti-HCV antibodies or HCV-RNA positive by PCR
- Compensated liver disease with the following minimum hematologic and biochemical criteria: hemoglobin ≥13 g/dl for males; ≥12 g/dl for females, white blood cell count > 3,000/mm3, neutrophil count >1,5000/mm3, platelets > 100,000/mm3, prothrombin time ≤ 2 seconds prolonged compared to control, or equivalent INR ratio, albumin stable and within normal limits, serum creatinine within normal limits, thyroid-stimulating hormone within normal limits, direct bilirubin ≤ 0.3 mg/dl or within 20% of upper limit of normal (ULN) for local laboratory, indirect bilirubin ≤ 0.8 mg/dl or within 20% of ULN for local laboratory, fasting blood sugar ≤ 115 mg/dl or within 20% of ULN for non-diabetic patients
- Negative pregnancy test for women of childbearing potential, and confirmation and documentation that adequate contraception or monogamous relationship with a male partner who has had a vasectomy during the treatment period and for 6 months after discontinuation of therapy
- Not breastfeeding
- Documentation and confirmation of adequate contraception in sexually active males
- Free from all psychotropic medications for 14 days prior to baseline visit (8 weeks for fluoxetine)
Who cannot join
- Evidence of untreated or poorly controlled endocrine, cardiovascular, hematological, renal, or neurological disease
- Evidence of decompensated liver disease (such as a history or presence of ascites, bleeding varices, spontaneous encephalopathy)
- History of narcolepsy, PLMS or sleep apnea (or documented during the adaptation night)
- History of CNS trauma or active seizure disorder requiring medication
- Any cause for liver disease other than chronic hepatitis C, such as co-infection with hepatitis B virus and/or human immunodeficiency virus, hemochromatosis, or Wilson's diseases
- Prior treatment with ribavirin or other antiviral or immunomodulatory drugs, including corticosteroids within 6 months of entry into protocol
Show all 18Show fewer
- Chronic use of agents known to affect monoamine metabolism/function (and hence potentially affect the TSST), including, but not limited to, alpha- and beta-receptor agonists and antagonists, methylphenidate hydrochloride, dextroamphetamine, midodrine hydrochloride, theophylline, ephedrine, systemic antifungal azoles, sumatriptan succinate
- Psychotropic medications within 14 days prior to baseline visit (8 weeks for fluoxetine)
- Clinical gout
- Hypersensitivity to alpha interferon or ribavirin
- Hemoglobinopathies (e.g. thalassemia)
- A positive pregnancy test
- Organ transplants
- A score of <24 on the Mini Mental Status Exam (MMSE)
- Active, effective treatment of depression with an antidepressant within the past six months
- Actively meet criteria for major depression within the past six months
- Meet criteria for schizophrenia or bipolar disorder (mania) past or present
- Active abuse of alcohol or illicit/prescription drugs within the past year any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University
Atlanta, Georgia
University of Arizona
Tucson, Arizona, 85724
About this study
Official title: Inflammation, Stress and Social Behavior: Using Ecological Assessments and Model Systems to Enhance Relevance to Health Outcomes
The current study has been designed to identify behavioral and physiological mechanisms through which positive social connectivity (PCS) and negative social processes (NSP) interact with psychosocial stress to promote resilience in the context of illness. The investigators model inflammation (a central element of all disease states) through the use of treatment with interferon (IFN)-alpha, which provides a standardized regimen of chronic cytokine exposure known to produce profound behavioral disturbances, including depression, fatigue and sickness, in a high percentage of individuals. To objectively assess social processes, the current project will employ the Electronically Activated Recorder (EAR), which periodically and unobtrusively records snippets of ambient sounds in people's momentary environments. To objectively assess behavioral and physiological responses to psychosocial stress the current project will employ the Trier Social Stress Test (TSST), a standardized laboratory stressor known to reliably activate behavioral, neuroendocrine and inflammatory responses. These novel methodologies and model systems will be employed to test the hypotheses that (a) pre-existing affiliative and prosocial behavior will promote resilience in the context of chronic inflammation and that (b) -conversely-chronic inflammation will reduce affiliative and prosocial behavior via effects on stress reactivity, neuroendocrine function and sleep. Finally, it will explore (c) the potential mediating role of stress physiology. To test these hypotheses, 110 subjects with chronic hepatitis C virus infection will be randomized to receive treatment with pegylated IFN-alpha plus ribavirin or to postpone treatment for 6 weeks: 55 subjects at University of Arizona and 55 subjects at Emory University. Prior to randomization and 6 weeks later all subjects will be evaluated with the EAR and sleep actigraphy in their home environments and will undergo TSST and 14 hour diurnal neuroendocrine and immune measurement.
- Conditions
- Hepatitis C
- Being tested
- Interferon-alpha
- Keywords
- Hepatitis C, interferon, stress, social behavior
- Medical subject headings
- Hepatitis C, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-alphaDrug
Also called Pegintron®, Schering Plough, PEGASYS®, Roche
Hepatitis C patients who are eligible to receive IFN-alpha treatment and enrolled in this study will be treated with pegylated IFN-alfa-2b or pegylated IFN-alfa-2a plus ribavirin at a dose of 800-1,400 mg/d as determined by the treating gastroenterologist. All medication administration is for purely clinical indications as dictated by treating physicians. Any and all diagnostic or treatment issues related to potential treatment with IFN-alpha will be conducted by treating clinicians. Subjects will be randomized to start their clinical (non-research) treatment following completion of baseline assessments or to delay the start of their clinical (non-research) treatment by 7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HCV Interferon-alpha group | Active comparator | Subjects receiving treatment with interferon (IFN)-alpha for chronic hepatitis C virus infection. Receives: Drug: Interferon-alpha |
| HCV Control Group | Placebo comparator | Subjects delaying the start of treatment with interferon (IFN)-alpha for chronic hepatitis C virus infection by 7 weeks. Receives: Drug: Interferon-alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent time laughing
Measured: 7 weeks
Percent time expressing empathy for others
Measured: 7 weeks
Percent of time spent in substantive conversations
Measured: 7 weeks
Percent of time spent alone
Measured: 7 weeks
Secondary outcomes (9)
Cortisol concentrations in blood in response to stress test
Measured: 7 weeks
Interleukin (IL)-6 concentrations in the blood in response to stress test
Measured: 7 weeks
Diurnal plasma concentrations of interleukin-6 and tumor necrosis factor-alpha type II receptors in response to a stress test
Measured: 7 weeks
Diurnal plasma concentrations of inflamcortisol in response to a stress test
Measured: 7 weeks
Wake time after sleep onset measured by actigraphy
Measured: 7 weeks
Sleep latency by measured by actigraphy
Measured: 7 weeks
Total sleep time by actigraphy
Measured: 7 weeks
Sleep efficiency by actigraphy
Measured: 7 weeks
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology (SIGH-IDS)
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: New medication coming on the market, made study obsolete.
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 ArizonaThe 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Charles L. Raison, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625793
- Sponsor's protocol ID
- 12-0166-02
- Other IDs
- 5R01AT007297-03
- Status last verified
- Jul 2013
- First submitted
- 11 Jun 2012
- Last updated
- 22 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation, Stress and Social Behavior: Using Ecological Assessments and Model Systems to Enhance Relevance to Health Outcomes
- ClinicalTrials.gov ID
- NCT01625793
- Acronym / sponsor ID
- 12-0166-02
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, interferon, stress, social behavior
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: New medication coming on the market, made study obsolete.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Emory University, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jun 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Jun 2012 (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 current study has been designed to identify behavioral and physiological mechanisms through which positive social connectivity (PCS) and negative social processes (NSP) interact with psychosocial stress to promote resilience in the context of illness. The investigators model inflammation (a central element of all disease states) through the use of treatment with interferon (IFN)-alpha, which provides a standardized regimen of chronic cytokine exposure known to produce profound behavioral disturbances, including depression, fatigue and sickness, in a high percentage of individuals. To objectively assess social processes, the current project will employ the Electronically Activated Recorder (EAR), which periodically and unobtrusively records snippets of ambient sounds in people's momentary environments. To objectively assess behavioral and physiological responses to psychosocial stress the current project will employ the Trier Social Stress Test (TSST), a standardized laboratory stressor known to reliably activate behavioral, neuroendocrine and inflammatory responses. These novel methodologies and model systems will be employed to test the hypotheses that (a) pre-existing affiliative and prosocial behavior will promote resilience in the context of chronic inflammation and that (b) -conversely-chronic inflammation will reduce affiliative and prosocial behavior via effects on stress reactivity, neuroendocrine function and sleep. Finally, it will explore (c) the potential mediating role of stress physiology. To test these hypotheses, 110 subjects with chronic hepatitis C virus infection will be randomized to receive treatment with pegylated IFN-alpha plus ribavirin or to postpone treatment for 6 weeks: 55 subjects at University of Arizona and 55 subjects at Emory University. Prior to randomization and 6 weeks later all subjects will be evaluated with the EAR and sleep actigraphy in their home environments and will undergo TSST and 14 hour diurnal neuroendocrine and immune measurement.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV Interferon-alpha group | Active comparator | Drug: Interferon-alphaSubjects receiving treatment with interferon (IFN)-alpha for chronic hepatitis C virus infection. |
| HCV Control Group | Placebo comparator | Drug: Interferon-alphaSubjects delaying the start of treatment with interferon (IFN)-alpha for chronic hepatitis C virus infection by 7 weeks. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 21-65 years including males, females and minorities
- Ability to speak and read remedial English
- Serum positive for either anti-HCV antibodies or HCV-RNA positive by PCR
- Compensated liver disease with the following minimum hematologic and biochemical criteria: hemoglobin ≥13 g/dl for males; ≥12 g/dl for females, white blood cell count > 3,000/mm3, neutrophil count >1,5000/mm3, platelets > 100,000/mm3, prothrombin time ≤ 2 seconds prolonged compared to control, or equivalent INR ratio, albumin stable and within normal limits, serum creatinine within normal limits, thyroid-stimulating hormone within normal limits, direct bilirubin ≤ 0.3 mg/dl or within 20% of upper limit of normal (ULN) for local laboratory, indirect bilirubin ≤ 0.8 mg/dl or within 20% of ULN for local laboratory, fasting blood sugar ≤ 115 mg/dl or within 20% of ULN for non-diabetic patients
- Negative pregnancy test for women of childbearing potential, and confirmation and documentation that adequate contraception or monogamous relationship with a male partner who has had a vasectomy during the treatment period and for 6 months after discontinuation of therapy
Key exclusion criteria (18 listed)
- Evidence of untreated or poorly controlled endocrine, cardiovascular, hematological, renal, or neurological disease
- Evidence of decompensated liver disease (such as a history or presence of ascites, bleeding varices, spontaneous encephalopathy)
- History of narcolepsy, PLMS or sleep apnea (or documented during the adaptation night)
- History of CNS trauma or active seizure disorder requiring medication
- Any cause for liver disease other than chronic hepatitis C, such as co-infection with hepatitis B virus and/or human immunodeficiency virus, hemochromatosis, or Wilson's diseases
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 |
|---|---|---|
| Interferon-alphaAlso: Pegintron®, Schering Plough, PEGASYS®, RocheHepatitis C patients who are eligible to receive IFN-alpha treatment and enrolled in this study will be treated with pegylated IFN-alfa-2b or pegylated IFN-alfa-2a plus ribavirin at a dose of 800-1,400 mg/d as determined by the treating gastroenterologist. All medication administration is for purely clinical indications as dictated by treating physicians. Any and all diagnostic or treatment issues related to potential treatment with IFN-alpha will be conducted by treating clinicians. Subjects will be randomized to start their clinical (non-research) treatment following completion of baseline assessments or to delay the start of their clinical (non-research) treatment by 7 weeks. | Drug | HCV Control Group, HCV Interferon-alpha group |
Primary outcome
Percent time laughing
Time frame: 7 weeks
Percent time expressing empathy for others
Time frame: 7 weeks
Percent of time spent in substantive conversations
Time frame: 7 weeks
Percent of time spent alone
Time frame: 7 weeks
9 secondary outcomes
Cortisol concentrations in blood in response to stress test
Time frame: 7 weeks
Interleukin (IL)-6 concentrations in the blood in response to stress test
Time frame: 7 weeks
Diurnal plasma concentrations of interleukin-6 and tumor necrosis factor-alpha type II receptors in response to a stress test
Time frame: 7 weeks
Diurnal plasma concentrations of inflamcortisol in response to a stress test
Time frame: 7 weeks
Wake time after sleep onset measured by actigraphy
Time frame: 7 weeks
Sleep latency by measured by actigraphy
Time frame: 7 weeks
Total sleep time by actigraphy
Time frame: 7 weeks
Sleep efficiency by actigraphy
Time frame: 7 weeks
Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology (SIGH-IDS)
Time frame: 7 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
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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.
Charles L. Raison, MD principal investigator
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interferon-alpha in people with Hepatitis C, run by University of Arizona 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 8 inclusion and 18 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: withdrawn, as of the sponsor's last update on 22 Jul 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percent time laughing (time frame: 7 weeks). The study lists 4 primary outcomes in all. 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 22 Jul 2013.