UMDNJ Magazine - fall 2004 VOLUME 1 NUMBER 1

Healthy volunteers at risk for colorectal cancer are needed for a clinical trial at The Cancer Institute of New Jersey in New Brunswick. The trial is looking to see if an aspirin-like drug or a substance found in curry and mustard can prevent the development of colorectal polyps.

A colorectal screening colonoscopy is provided to volunteers at Robert Wood Johnson University Hospital in New Brunswick as part of this investigation. Compensation is offered to offset the costs of participation.

Steven J. Shiff, MD, is the principal investigator. For more information contact The Cancer Institute of New Jersey at 1-866-654-9898 and select option 1.

Acid Reflux

A study being conducted at The Cancer Institute of New Jersey and Robert Wood Johnson University Hospital in New Brunswick is designed to detect people who may develop Barrett's esophagus (BE). Chronic acid reflux can, over time, cause damage to the white lining of the esophagus, replacing it with an abnormal red lining called Barrett's esophagus. Over time, BE can develop into esophageal cancer. The study's goal is to ultimately prevent the onset of esophageal cancer.

To be eligible to participate, volunteers must have symptoms related to acid reflux and it must be at least one year since their last upper endoscopy. Those who show signs of being susceptible to BE may also be eligible for a prevention study upon completion of the acid reflux trial.

Kiron Das, MD, PhD, is the principal investigator. For more information or to participate, contact The Cancer Institute of New Jersey at 1-866-654-9898 and select option 3.

Diabetes

A research study for an investigational drug for Type II diabetes is being evaluated in the Department of Medicine at Cooper Hospital/University Medical Center in Camden. The study is seeking volunteers who have Type II diabetes that is not currently being treated with medication. To be eligible for participation, volunteers must be between the ages of 25 and 75 and have Type II diabetes. They must be using diet and exercise to treat the condition and not be taking medication to control the diabetes.

Those who qualify will receive study-related procedures and study medication at no cost. In addition, they will be compensated for their time and travel.

Arnaud Bastien, MD, is the principal investigator. For more information call Dr. Bastien or Patricia Niblack, MLT, CRC, at 856-968-7269.

High Blood Pressure

Physicians at Cooper Hospital/University Medical Center in Camden are looking for volunteers to participate in a research study on high blood pressure. The study will use two combinations drugs already approved to lower blood pressure. It is designed to evaluate these medications to see if they will reduce the occurrence of future health complications associated with high blood pressure. To qualify, volunteers must be age 55 or older, have high blood pressure, and have or have had heart problems, circulation problems, kidney problems, stroke or diabetes.

All study-related care and investigational medication will be provided at no cost.

The principal investigator is Arnaud Bastien, MD. For more information call Dr. Bastien or Patricia Niblack, MLT, CRC, in the Department of Medicine, at 856-968-7269.

Asthma

The Department of Medicine at Cooper Hospital/University Medical Center in Camden is currently recruiting volunteers to participate in an asthma study. Participants must be non-smokers between the ages of 15 and 65 with a history of asthma. The study offers free testing, examinations and generous compensation for participants' time and travel.

The principal investigator is Robin Gross, MD. For more information contact either Robin Gross, MD, at 856-342- 2407, or Patricia Niblack, MLT, at 856-968-7269.

Osteoarthritis

The Department of Medicine at UMDNJ-School of Osteopathic Medicine in Stratford is testing an investigational medication for the treatment of osteoarthritis of the hip and knee. The objective is to compare the analgesic efficacy and safety of 8mg and 16mg Dilaudid CR (controlled-release hydromorphone) to placebo. The duration is approximately four months and will require about 13 office visits. Study participants must be age 21 or older. Subjects will receive study related medical care and study medication at no cost. They will be reimbursed $20 for each completed visit.

Stephen Burnstein, DO, is the principal investigator. For more information call 856-566-7075.

The Treatment of Fibromyalgia

The Department of Medicine at UMDNJ-School of Osteopathic Medicine in Stratford is testing an investigational medication for the treatment of fibromyalgia. 48 U M D N J magazine The duration of the study is 27 weeks with the option of entering an extension study for an additional 28 weeks of therapy. The study is designed to demonstrate the safety and effectiveness of milnacipran in treating this syndrome. Those who qualify will receive study related medical care and study medications at no cost. Participants will be compensated $15 for each visit to cover the cost of transportation.

Stephen Burnstein, DO, is the principal investigator. For more information contact Karen Maslowski, study coordinator, at 856-566-7075 or Patty DiVito at 856-566-6850.

Psychiatric Disorders

A research study investigating the potential for the development of cataracts in individuals with schizophrenia is being conducted at UMDNJ-School of Osteopathic Medicine in Stratford. The study will be conducted over a two-year period and will require 28 visits.

To be eligible, participants must be between the ages of 18 and 65 and diagnosed with schizophrenia or schizoaffective disorder. Participants will receive either Seroquel or Risperdal. Monetary compensation will be provided for time and travel.

David Rissmiller, DO, is the principal investigator. For more information call Louise at 1-888-602-9900.

Borderline Personality Disorder

Volunteers are needed to participate in a study conducted at UMDNJ-School of Osteopathic Medicine in Stratford to assess whether the antipsychotic drug Zyprexa (olanzapine) will be effective in controlling symptoms of borderline personality disorder (BPD). To be eligible, volunteers must be between the ages of 18 and 65 and diagnosed with BPD. The study will last up to 24 weeks. Participants will be closely monitored by a faculty psychiatrist. They will receive study medication at no cost and will be compensated up to $600 upon completion of the study.

David Rissmiller, DO, is the principal investigator. For more information call Louise at 1-888-602-9900.

Dementia

UMDNJ-School of Osteopathic Medicine in Stratford is conducting a two-year study to assess the management of Alzheimer's patients. Volunteers with mild to moderate Alzheimer's disease and their caretakers are needed to participate. Caretakers will be required to complete questionnaires during the study's four-visit course. Participants will receive study-related exams at no cost.

The principal investigator for the study is Anita Chopra, MD. For more information contact Marsha Sogle, RN, CCRC, Center for Aging, at 856-566-6003.

Type II Diabetes Mellitus

Volunteers are being sought to participate in an investigational drug study of a new diabetes pill for the treatment of Type II diabetes mellitus. The Department of Medicine at UMDNJ-Robert Wood Johnson Medical School in New Brunswick is conducting the study. To be eligible, participants must be between the ages of 18 and 80. A physical exam, study medications and relevant laboratory tests will be provided at no cost. Upon completion, monetary compensation will be provided.

Stephen H. Schneider, MD, is the principal investigator. For more information call Shelley Greenhaus, RN, at 732-235-7751.

Type II Diabetes

The Department of Medicine at UMDNJ-Robert Wood Johnson Medical School in New Brunswick is looking for volunteers to participate in a study of new diabetes treatments. To qualify, participants must be between the ages of 30 and 75, have Type II diabetes and currently be undergoing treatment with Lantus (insulin glargine) in combination with one or two oral diabetic medications.

All study-related care, physical examinations, glucose meters and supplies, study medication and laboratory tests are provided at no cost.

Stephen H. Schneider, MD, is the principal investigator. For additional information call 732-235-7751.

Managing Type II Diabetes

Managing Type II diabetes is the goal of a study being conducted in the Department of Medicine at UMDNJRobert Wood Johnson Medical School in New Brunswick. Volunteers between the ages of 18 and 80, taking more than one oral medication to treat Type II diabetes, and who are interested in trying a new delivery system for managing this condition, are needed for participation. The study will compare the effects of a combination of oral diabetes medications with that of inhaled insulin taken with a combination of oral diabetes medications, or inhaled insulin taken with a single oral diabetes medication.

Volunteers may be eligible to receive investigational inhaled insulin in a clinical trial. Qualified participants will receive confidential, study-related exams from diabetes specialists, nutritional counseling, laboratory tests, a home blood sugar testing machine, and all study medication at no charge. Volunteers who smoke or have a severe medical condition will not be eligible to participate.

Stephen H. Schneider, MD, is the principal investigator. For more information contact Shelley Greenhaus, RN, at 732-235- 7751 between 2 and 4 PM.

Osteoporosis

An osteoporosis research study is being conducted in the Department of Medicine at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. Generally healthy postmenopausal women who are not taking other drugs for osteoporosis may be eligible to participate. They may receive an investigational drug, bone density tests, calcium supplements and travel compensation. In addition, visits and evaluations may be required.

Stephen H. Schneider, MD, is the principal investigator. For more information call Shelley Greenhaus, RN, at 732-235-7751.

Bone Loss

The Women's Health Institute at UMDNJRobert Wood Johnson Medical School in New Brunswick is in need of postmenopausal women between the ages of 50 and 65 who are concerned about bone loss to participate in an 18-month research study. Women who are in general good health and are not on any medications for treatment or prevention of osteoporosis may be eligible for participation. Participants will receive a complete physical exam, bone density scans, lab tests and investigational medication at no cost. Upon completion of the study, monetary compensation up to $200 will be provided.

Gloria A. Bachmann, MD, is the principal investigator. For more information call 732-235- 7353, Monday through Friday, between 8 AM and 4 PM.

Women's Research

A research study for women is being conducted at UMDNJ-Robert Wood Johnson Medical School in New Brunswick for the treatment of heavy menstrual bleeding. The goal of the project is to determine if this condition is due to an underlying bleeding disorder. To be eligible to participate, volunteers must be between the ages of 13 and 55. Those who qualify will be compensated $50 for their participation.

Claire Philipp, MD, Division of Hematology, is the principal investigator.

For more information contact Robin Schwartz, CCRC, at 732-235-6103.

Vitiligo

A study to determine the efficacy and safety of Etanercept to treat vitiligo (loss of normal skin color) is being conducted at the Clinical Research Center at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. The duration of the study is approximately seven months. Volunteers age 18 and older who have been diagnosed with vitiligo are eligible to participate.

The principal investigator is Alice B. Gottlieb, MD, PhD, director of the Clinical Research Center. For more information contact Nancy Olesinski at 732-418-8484.

Schizophrenia Research

Study for Adolescents The Division of Child and Adolescent Psychiatry at UMDNJ-Robert Wood Johnson Medical School in Piscataway is doing a medical research study to evaluate the safety and effectiveness of an atypical antipsychotic medication for adolescents who have symptoms of schizophrenia. To participate, volunteers must be between the ages of 13 and 17, and be experiencing any of the following symptoms:

disorganized speech that is incoherent at times;
seeing things that are not there;
often appearing distracted;
appearing to hear voices when no one is there;
an inability to focus on tasks;
disorganized thoughts and behaviors;
social withdrawal;
feeling like people are out to get them.

Health insurance is not needed to be eligible for participation.

Qualified participants will receive study related medication and study related evaluation - funded by a major pharmaceutical company.

The principal investigator is Theodore Petti, MD. For more information contact Kurt Bopp, clinical research coordinator, at 732-235-5690.

Childhood Autism

Volunteers between the ages of 5 and 17 are needed to participate in a 12-week clinical drug study on autism in the Division of Child and Adolescent Psychiatry at UMDNJ-Robert Wood Johnson Medical School in Piscataway. The purpose of the study is to explore treatment options for children with autism. To be eligible, participants must have a diagnosis of autism and they must be willing to undergo an interview. The interview and questionnaires may take four hours to complete. The interview can be completed at the second visit if necessary. Medication will be provided at no cost. Those who qualify will be closely monitored by the study doctor.

Sherie Novotny, MD, is the principal investigator. For more information call Kurt Bopp, clinical research coordinator, at 732-235-5690.

Schizophrenia and Anxiety

Participants are needed for a 16-week clinical drug study on schizophrenia and anxiety at UMDNJ-University Behavioral HealthCare, Extended Treatment, in New Brunswick. The purpose of the study is to explore treatment options for individuals with schizophrenia and social anxiety symptoms. To be eligible, volunteers must be between the ages of 18 and 65, have a diagnosis of schizophrenia or schizoaffective disorder, and be willing to undergo an interview. Those who qualify may receive up to $280 for participation and an additional $20 for each visit, if travel is involved.

Theodore Petti, MD, MPH, is the principal investigator. Contact Kurt Bopp, clinical research coordinator, for more information about the study at 732-235-5690.

Low Sexual Desire in Wome

The Department of Psychiatry at UMDNJ-Robert Wood Johnson Medical School in Piscataway is conducting a medication research study for women taking an antide- pressant but who continue to have problems with low sexual desire. The purpose is to evaluate the effectiveness of a medication approved for the treatment of sexual dysfunction in men for women with low sexual desire. The duration of the study is approximately six months. Volunteers must be between the ages of 18 and 50. All study-related procedures are provided at no cost.

The principal investigator is Matthew Menza, MD. For more details call Roseanne Dobkin, PhD, at 1-877-795- 4673 (toll free).

Parkinson's Disease and Depression

A study of depression in patients with Parkinson's disease (PD), using medications approved for depression, is being conducted at UMDNJRobert Wood Johnson Medical School in Piscataway. The study is funded by the National Institutes of Health. To be eligible, participants must have PD and be experiencing the following:

getting more and more isolated;
feeling sad or empty most of the day;
difficulty falling asleep or staying asleep;
loss of interest in daily activities;
inability to concentrate.

An extensive psychiatric evaluation is provided at no cost. Participants will be compensated $30 for each study visit.

Matthew Menza, MD, is the principal investigator. For further details call Allison Dicke, toll free, at 1-877-795-4673.

Depression

Volunteers between the ages of 18 and 65 who have not responded to treatments for depression are needed to participate in a study evaluating new medications at UMDNJRobert Wood Johnson Medical School in Piscataway. Participants must have experienced several of the following: feelings of sadness, guilt, hopelessness, or worthlessness; loss of interest in pleasurable activities; difficulty sleeping; difficulty concentrating or making decisions; changes in appetite or weight; persistent physical symptoms such as headache, digestive problems and chronic pain to be eligible to participate. Compensation of $30 per visit will be provided. The maximum compensation upon completion of study is $690.

Matthew Menza, MD, is the principal investigator. For more information call Baher Georgy (toll free) at 1-877- RWJ-HOPE.

Generalized Anxiety Disorder

UMDNJ-Robert Wood Johnson Medical School in Piscataway is conducting a study of investigational medications for treatment-resistant generalized anxiety disorder (GAD). To be eligible to participate, volunteers must suffer from excessive worry, nervousness, restlessness, irritability, sleeping problems and an inability to concentrate. All research care, including an extensive psychiatric evaluation, is provided at no cost. Participants will be paid $30 for each study visit.

Matthew Menza, MD, is the principal investigator. For additional information call Regine Rousso, toll free, at 1-877-RWJ-HOPE (1-877-795-4673).

Health Effects of Hydrogen Sulfide

UMDNJ-Robert Wood Johnson Medical School in Piscataway is seeking volunteers to participate in a research study that will investigate the health effects of hydrogen sulfide. To be eligible, volunteers must be healthy non-smokers between the ages of 20 and 40. They will be required to complete four consecutive weekly sessions of four hours, measurement of responses to typical environmental levels of hydrogen sulfide (rotten egg smell), questionnaires, and tests of attention/concentration. Nasal and blood samples will be collected. All sessions will take place in the mornings on the Busch campus at the Environmental & Occupational Health Sciences Institute on Frelinghuysen Road in Piscataway. Upon completion of the study, participants will receive up to $450.

Nancy Fiedler, PhD, Environmental & Occupational Health Sciences Institute, is the principal investigator of the study. For more information call 732-445-0123, ext. 625.

Oral Cancer

A clinical trial is underway to evaluate the effects of green tea on leukoplakia in the oral cavity. The study is being conducted by UMDNJ-New Jersey Dental School's Division of Oral Medicine in conjunction with The Cancer Institute of New Jersey in New Brunswick. Oral cancer is the most common cancer of the head and neck region and has a high morbidity rate. With early detection and proper treatment, patients' quality of life can be significantly improved. Leukoplakia may appear in the mouth as a white adherent patch or plaque. Patients with a diagnosis of oral dysplasia, or who require further evaluation for leukoplakic lesions of the oral cavity, may be eligible to participate in the study. Those who qualify will be required to take green tea lozenges each day for 12 weeks.

Susan Goodin, PharmD, is the principal investigator. For more information call Dr. Parisi at the dental school in Newark at 973-972-7211 or 973-972- 3418, or email parisier@umdnj.edu ; or call The Cancer Institute of New Jersey at 732-235-CINJ or 1-866-654-9898, or visit www.cinj.org.