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Clinical Trials:
Call for Volunteers

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 Lisa Giffin, LPN,CCRC, Center for Aging, at 856-566-6356.

Anemia and Chronic Kidney Disease
Volunteers who have anemia associated with chronic kidney disease are needed to participate in a three-year research study. The goal of the study is to determine if the level of anemia affects how often heart disease related illnesses occur. Weekly study visits are required and the study drug PROCRIT® will be provided at no cost.

The study is being conducted at UMDNJ-School of Osteopathic Medicine in Stratford. Thomas Cavalieri, DO, is the principal investigator. For additional information contact study coordinators Terry Koch, RN, at 856-566-5478 or Karen Maslowski, RN, at 856-566-7075.

Anemia and Chemotherapy
A study is being conducted at UMDNJ-School of Osteopathic Medicine in Stratford on anemia associated with chemotherapy given for cancer. Anemia is a common occurrence in patients being treated for cancer. Both erythropoietin (EPO) and iron are needed to make red blood cells healthy and plentiful. The body may need additional iron when taking EPO. Only volunteers undergoing chemotherapy for cancer and EPO therapy for
anemia are eligible. The study will assess red blood cell counts in subjects receiving EPO versus EPO plus intravenous Venofer (iron sucrose). The 21-week study involves weekly visits.

Nathan Freed, DO, is the principal investigator. For more information contact Karen Maslowski, RN, at 856-566-7075.

Migraine Headache
The UMDNJ-School of Osteopathic Medicine’s University Headache Center in Moorestown is looking for volunteers between the ages of 18 and 60 to participate in a migraine headache study on behalf of NPS Pharmaceuticals, Inc. An investigational medication for treatment of migraines will be tested. After free physical exams and blood tests, participants will document their headache histories. They will also be treated for one migraine attack. If needed, taxi service will be provided and monetary compensation for time and travel is available.

The principal investigator for the study is R. Michael Gallagher, DO. For additional information call the University Headache Center at 856-234-7421.

High Blood Pressure (Hypertension)
The Department of Family Medicine at Cooper Hospital/University Medical Center, the core teaching site of UMDNJ-Robert Wood Johnson Medical School at Camden, is one of more than 100 sites in the U.S. participating in a new drug study for patients with high blood pressure (hypertension). The duration of the study is 11 to 12 weeks.The purpose of the study is to compare two currently marketed medications to a sugar pill (placebo) in reducing blood pressure. Volunteers age 18 and older who have high blood pressure may be eligible to participate. Participants will receive lab work, study visits (after initial visits, participants will be seen approximately every two weeks), ECG and medication at no cost.

Tracy Brobyn,MD, is the principal investigator. For more information call 856-321-0140.

High Cholesterol
Cooper Hospital/University Medical Center in Camden is looking for South Asians (descendants of India, Pakistan, Bangladesh, Sri Lanka, Nepal, or Bhutan) age 18 or older to participate in an investigational research study of a FDA-approved medication for high cholesterol. Eligible participants will receive study-related physical exam, study-medication, diet counseling and study-related laboratory tests at no cost.

Tracy Brobyn, MD, is the principal investigator. For more information call the IRIS Study at 856-321-0140.

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.

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

Colorectal Cancer
Healthy volunteers at risk for colorectal cancer are needed for a clinical trial currently underway at The Cancer Institute of New Jersey in New Brunswick. The study will evaluate if curcumin, a substance found in curry and mustard, can prevent the development of colorectal polyps. Preventing the formation of polyps is an effective way to prevent colorectal cancer.

A colorectral screening colonoscopy is provided to volunteers by Robert Wood Johnson University Hospital in New Brunswick. Compensation is offered to offset the cost of participation. Steven Shiff, MD, is the principal investigator. For more information call 732-235-CINJ or 1-866-654-9898 (toll free).

Breast Cancer
Medical oncologists at The Cancer Institute of New Jersey (CINJ) are conducting a multi-site national clinical research trial for women who are at increased risk for breast cancer.

The study will:

• compare the effectiveness of using the drugs tamoxifen or raloxifene to reduce the occurrence of breast cancer in women who are most susceptible to the disease; and,
• evaluate the risks associated with this new approach to stopping breast cancer before it starts.

Deborah Toppmeyer, MD, medical oncologist at CINJ, is the principal
investigator. For additional information or criteria for participation, call 732-235-0659.

Bone Loss Prevention
Women between the ages of 40 and 60 who are at least one year postmenopausal may be eligible for a bone loss prevention study at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. The study examines the effect of nitroglycerin ointment compared to plain ointment in stopping or slowing down bone thinning. Volunteers will receive a free bone density scan at their initial screening visit, as well as parking validation. Once randomized, volunteers will receive $25/visit.

Primary investigator is Sunil Wimalawansa, MD, PhD. Contact the NOVEL study at 732-235-8938 or on line (http://www2umdnj.edu/novelweb/NOEL).

Depression and Low Sexual Desire
Minority women are being sought to participate in a study for depression and low sexual desire at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. To be eligible to participate, volunteers must be taking antidepressant medication and have noticed a decrease in their sex drive. The study offers 10 weeks of free treatment for depression and sexual concerns, and will compensate each participant up to $150.

Matthew Menza, MD, and Roseanne Dobkin, PhD, are co-principal investigators for the study. For more information contact Dr. Dobkin at 732-235-4051.

A New Contraceptive Gel Study
The Women’s Health Institute in New Brunswick is conducting a seven-month research project to evaluate a new contraceptive gel with diaphragm. Women in good health between the ages of 18 and 40 are being sought to participate. Participants will receive study-related exams, contraception, and laboratory tests at no cost. Monetary compensation up to $200 will be provided to those who complete the study.

Charletta Ayers, MD, MPH, Women’s Health Institute at UMDNJ-Robert Wood Johnson Medical School, is the principal investigator. For more information call 732-235-7292, Monday thru Friday from 9 AM to 5 PM.

Managing Type II Diabetes
Managing Type II diabetes is the goal of a study being conducted in the Department of Medicine at UMDNJ-Robert 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.

Women’s Health
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.

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.

Psoriasis
A phase III, multi-center, randomized, double-blind, placebo-controlled trial is being conducted at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. The purpose is to evaluate the safety and efficacy of Infliximab induction therapy followed by multiple regimens of maintenance Infliximab therapy in subjects with plaque-type psoriasis. The study length is approximately 17 months. Volunteers must be ages 18 and older and have been diagnosed with psoriasis. Those who qualify will receive monetary compensation for their participation.

The principal investigator is Alice B. Gottlieb, MD, PhD, director of the Clinical Research Center. For additional information or to see if you qualify, call Nancy Olesinski at 732-418-8484.

Moderate to Severe Psoriasis
Volunteers are needed at the Clinical Research Center at UMDNJ-Robert Wood Johnson Medical School in New Brunswick to participate in a moderate to severe psoriasis study. The length of the study is approximately one year. To be eligible, volunteers must be between the ages of 18 and 80 and diagnosed with moderate to severe psoriasis. Participants will not receive monetary compensation for participation.

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

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.

Low Sexual Desire in Women
The Department of Psychiatry at UMDNJ-Robert Wood Johnson Medical School in Piscataway is conducting a medication research study for women taking an antidepressant 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 UMDNJ-Robert 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 UMDNJ-Robert Wood Johnson Medical School in Piscataway. To be eligable to particapate, 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. 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.

Major Depressive Disorder
An investigational research medication for major depressive disorder is being studied at UMDNJ-Robert Wood Johnson Medical School in Piscataway. To participate, volunteers must be age 18 or older, medically stable and sexually active. They must be experiencing some of the following:

• feelings of sadness or emptiness most of the day; loss of interest in daily activities; difficulty falling asleep or staying asleep; jumpiness, irritability or restlessness; and, inability to concentrate. All research care, including an extensive psychiatric evaluation, is provided at no cost. Those who qualify will be paid $35 for each study visit.

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

Depression and Social Support
A research study to examine the impact of certain types of social support on depression is being done at UMDNJ-Robert Wood Johnson Medical School in Piscataway. If you have experienced depression, feel less able to enjoy activities in life, have noticed changes in sleep, appetite, concentration or energy level and feel helpless, hopeless, or confused about where to turn, you may be eligible to participate. Eight to 10 sessions of cognitive
behavioral therapy will be provided as part of the study. A friend, family member, or significant other will be required to participate. Both the volunteer and partner will be compensated $150 for their participation.

For more information about the study, call principal investigator Roseanne Dobkin, PhD, at 732-235-4051.

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).