Studies
for Veterans of the Gulf War
The Department of Veterans Affairs, in conjunction with the Department of Defense,
is leading a $20 million effort to learn ways to improve the health of veterans
suffering from such symptoms as fatigue, muscle and joint pain and problems with
memory and thinking.
Despite the lack of a clinical case definition of the symptom complex called Gulf
War illness, the VA has identified subgroups of patients for whom certain therapies
may be appropriate.
The two studies that will be completed at the Department of Veterans Affairs New
Jersey Health Care System in East Orange are the Antibiotic Therapy Trial (ABT)
and the Exercise Therapy and Behavior Therapy Trial (EBT). Subjects will receive
Doxycycline or placebo in the antibiotic trial. For the EBT, subjects will receive
the aerobic exercise and/or behavior therapy, or the usual and customary care.
Behavioral and exercise therapies have both been shown to be effective in treating
various chronic ailments. The antibiotic Doxycycline (a tetracycline) may be effective
in relieving symptoms related to mycoplasma infection which has been found in
some Gulf War veterans.
To be eligible to participate, subjects must have served in the Persian Gulf War
between August 1990 and August 1991. They must currently be suffering from at
least two of the three symptoms of fatigue, muscle and joint pain, and memory
and other neurologic problems. To participate in the antibiotic treatment trial,
subjects must test positive for infection with mycoplasma. This screening will
be provided at the initial assessment.
The principal investigator for the ABT is Lisa Dever, MD. Lana Tiersky, PhD, is
the principal inves- tigator for the EBT. For referral, contact Donna Heinzen
at the VA New Jersey Health Care System in East Orange at 800-248-8005.
New Medication for
High Blood Pressure and
Diabetic Kidney Disease
Hypertension specialists at UMDNJ-Robert Wood Johnson Medical School in
New Brunswick are conducting a study to compare the ability of an investigational
medication to reduce the amount of protein in the urine of Type II diabetes patients
with a medication currently on the market to treat high blood pressure. The study
is for 16 weeks and those eligible must be 18 or older with hypertension and Type
II diabetes. Participants will receive study medications, physical exams, blood
pressure monitoring, laboratory tests, EKGs and chest x-rays at no cost. Monetary
compensation is available to those who complete the studies.
The study is under the direction of the principal investigator, Michael C. Ruddy,
MD. For more information call Noreen Bradley, RN, at 732-235-7825.
Psoriasis
The Clinical Research Center at UMDNJ-Robert Wood Johnson Medical School in New
Brunswick is seeking volunteers with psoriasis to participate in research studies
being conducted at the school. Eligible participants will receive physical examinations
by board- certified dermatologists, laboratory tests and medication at no cost.
Some programs have monetary compensation.
This study is under the direction of Alice B. Gottlieb, MD, PhD. For further details
and to find out if you qualify, call study coordinator Amelia Sherr, RN, at 732-418-8474.
Cancer Clinical Trials
Scientists at The Cancer Institute of New Jersey (CINJ) in New Brunswick develop
and conduct clinical trials for oncology patients who do not respond to traditional
therapies and for those with cancers that do not have a standard treatment. The
focus of these studies is to develop new treatment options and drugs, as well
as preventive and diagnostic techniques to fight the disease.
CINJ is currently conducting more than 60 clinical trials. For additional information,
call the Clinical Research Office at 732-235-8666.
Neck and Shoulder Pain
A seven-week research study is being conducted at the Kessler Medical Rehabilitation
Research and Education Corporation (located within Kessler Institute for Rehabilitation)
in West Orange on pain or muscle spasm in the shoulders and/or neck. To be eligible
to participate, volunteers must be women between the ages of 20 and 45 who suffer
from these symptoms. Participants will receive a full medical evaluation and free
medication.
Scott Nadler, DO, and Gerard Malanga, MD, are the principal investigators of the
study. For more information call 973-972-2802.
Hypertension Studies
Volunteers age 21 and older with high blood pressure are being sought to participate
in a study to evaluate the effectiveness of dietary salt restriction on blood
pressure variability. The study is being conducted at UMDNJ-Robert Wood Johnson
Medical School in New Brunswick by the Section of Hypertension. Volunteers must
have high blood pressure or be taking an antihypertensive medication. Participants
who complete the study will receive monetary compensation.
A second study is being conducted at the school to determine the effects of an
FDA-approved medication, Cardura, for hypertension and blood pressure variability.
Volunteers age 18 and older are sought for participation in the study.
Both studies are under the direction of principal investigator Michael C. Ruddy,
MD. For additional information call Noreen Bradley, RN, at 732-235-7825.
The Study of Tamoxifen and Raloxifene to Prevent Breast
Cancer
The Cooper Cancer Institute in Voorhees has been selected to participate in the
National Surgical Adjuvant Breast and Bowel ProjectÕs (NSABP) Study of Tamoxifen
and Raloxifene (STAR). The study, sponsored by the National Cancer Institute (NCI),
needs 22,000 women to participate nationwide. Volunteers must be postmenopausal
women age 35 and older who are at increased risk for developing breast cancer.
In STAR, the drugs tamoxifen and raloxifene will be compared for their effectiveness
in reducing the occurrence of breast cancer in postmenopausal women. Participants
will receive either tamoxifen or raloxifene for five years.
The principal investigator for the study is Generosa Grana, MD. For more information
call the Cooper Cancer Institute at 856-325-6757. Head and Neck Cancer A study
is being conducted at the Cooper Cancer Institute in Voorhees for individuals
with metastatic or recurrent head and neck cancer. The new drug, Cetuximab, not
yet approved by the FDA, will be given in conjunction with chemotherapy. The objectives
of the study are to examine the safety and effectiveness of the treatment, and
to allow the patients a better quality of life. Alex Hageboutros, MD, is the principal
investigator of the study. For more information call the Cooper Cancer Institute
at 856-325-6757.
A Study for Those at Risk for Cardiovascular Events
The Division of Cardiovascular Disease and Hypertension of UMDNJ-Robert Wood Johnson
Medical School in New Brunswick is looking for volunteers to participate in a
study for men and women age 65 and older. OPERA (Omapatrilat in Persons with Enhanced
Risk of Atherosclerotic Events) is a five-year program designed to find out whether
treating persons with borderline blood pressure and additional risk factors will
reduce the risk of heart attack, heart failure or stroke. These risk factors include
high cholesterol, high blood sugar (diabetes), smoking and blockages in the arteries
of the heart (coronaries) or the neck (carotid).
OPERA is an international research project led by investigators at the medical
school and sponsored by Bristol-Myers Squibb. The research project will be offered
at 900 centers worldwide. It will include approximately 12,600 participants with
ÒborderlineÓ high blood pressure. Participants with systolic blood pressure of
140-159 mmHg (130-149 mmHg if diabetic) and normal (below 90 mmHg) diastolic pressure
will be given either omapatrilat, an investigational medication, or placebo, an
inert substance or Òsugar pill,Ó and will be followed for up to five years. Participants
will be given free study medication, electrocardiograms, laboratory tests and
periodic checkups. Individuals on medication to lower their high blood pressure,
including diuretics (or Òwater pillsÓ), are not eligible.
The principal investigator for the study is John B. Kostis, MD. For more information
about the study, call Melissa Levine or Shannon Monahan at 732-235-7871.
Treatment for Resistant Depression
The Department of Psychiatry at UMDNJ-Robert Wood Johnson Medical School in Piscataway
is conducting a study on the effectiveness of olanzapine and fluoxetine for depression.
The study will test the hypothesis that combined doses of olanzapine and fluoxetine
are more effective than separate selective doses of olanzapine, fluoxetine and
nortriptyline in the treatment of individuals with depression. Study participants
must be between the ages of 18 and 65 and have failed to achieve a satisfactory
antidepressant response to a selective serotonin reuptake inhibitor for four weeks
at a minimum acceptable dose. Participants will receive study medications, physical
exams and laboratory tests at no charge. Maximum study duration is 40 weeks.
Matthew Menza, MD, is the principal investigator for this study. For further information
regarding the study, call Karen Jimenez, PhD, at 732-235-4051 or 1-877-RWJ-HOPE.
Investigational Drug Study
Researchers at UMDNJ-Robert Wood Johnson Medical School in New Brunswick
are seeking volunteers with diabetes, age 18 and older, to participate in a new
investigational drug study. The purpose of the study is to determine the drugÕs
effectiveness in improving the bodyÕs response to insulin. Eligible participants
will receive a physical examination, study medications and relevant laboratory
tests at no cost.
Stephen H. Schneider, MD, is the principal investigator of the study. For more
information call Shelley Greenhaus, RN, at 732-235-7751.
Loss of Sexual Desire Associated with Menopause
A research study is being conducted at UMDNJ-Robert Wood Johnson Medical School
in New Brunswick to determine the effects of an investigational drug in the treatment
of loss of sexual desire associated with menopause. Volunteers in good health
between the ages of 40 and 65, who no longer have menstrual periods and have been
on estrogen treatment for at least three months are eligible to participate. In
addition, participants must be in a stable heterosexual relationship and have
experienced the loss of sexual desire since the onset of menopause. The duration
of the study is approximately 18 weeks with an optional six-month treatment extension.
Those accepted will receive a free physical exam, Pap smear, laboratory tests
and medication. Upon completion of the study, participants will receive compensation
of $125 for their time and travel.
The principal investigator for this study is Gloria Bachmann, MD. For more information
call the WomenÕs Health Research Section, Monday through Friday from 9 am to 5
pm, at 732-235-7799, 732-235-7353 or 732-235-7925.
Treatment Program for Perimenopause
Women in good general health between the ages of 35 and 50, who have recently
experienced changes in their menstrual pattern, are not on birth control pills
and who may or may not have symptoms such as hot flashes, are eligible to participate
in a six-month hormone treatment program for perimenopause. Participants will
receive a physical exam and Pap smear, laboratory tests, a mammogram and medication
at no cost. Those who complete the study will receive $175.
The studyÕs principal investigators are Gloria Bachmann, MD, and Jeffrey Levine,
MD. For additional information call the WomenÕs Health Research Section at UMDNJ-Robert
Wood Johnson Medical School in New Brunswick, Monday through Friday from 9 am
to 5 pm, at 732-235-7799, 732-235-7353 or 732-235-7925.
Study to Help Prevent Osteoporosis in Postmenopausal Women
Postmenopausal women are needed to participate in a 12-week treatment study
of a medication to help prevent osteoporosis at UMDNJ-Robert Wood Johnson Medical
School in New Brunswick. Volunteers must be age 65 or younger and in good health.
Participants will receive a free physical exam, Pap smear and laboratory tests.
Upon completion of the study, participants will receive $225.
Gloria Bachmann, MD, is the principal investigator. For more information call
the WomenÕs Health Research Section, Monday through Friday from 9 am to 5 pm,
at 732-235-7292 or 732-235-7353.
Cholesterol
Volunteers age 18 or older are needed to participate in an investigational drug
study at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. The purpose
of the study is to evaluate the effectiveness of a new slow-release form of Lescol
(an approved medication), which may lower blood cholesterol and risk of heart
disease. Participants will receive a physical exam, study medications and relevant
laboratory tests at no cost. Monetary compensation will be provided upon completion
of the study.
Avedis K. Khachadurian, MD, is the principal investigator. For more information,
call Shelley Greenhaus, RN, at 732-235-7751.
New Investigational Medication for Hypertension
Hypertension specialists at UMDNJ-Robert Wood Johnson Medical School in New Brunswick
are conducting a study to evaluate the safety and effectiveness of a new investigational
medication for high blood pressure. The study is divided into two phases, a short-term
phase for approximately 13 weeks and a voluntary long-term extension that will
last up to one year. Volunteers age 18 and older are needed to participate in
both phases of the study.
Michael C. Ruddy, MD,
is the principal investigator for the study. For more information call Noreen
Bradley, RN, at 732-235-7825.
Diabetes
The Division of Endocrinology, Metabolism and Nutrition at UMDNJ-Robert Wood Johnson
Medical School in New Brunswick is conducting a study for patients, ages 30 through
70, with diabetes that is poorly controlled with pills as the sole therapy. The
goal of the study is to evaluate the benefits of a new investigational insulin
taken once at night. Participants will receive a physical exam, relevant laboratory
tests and study medications at no cost.
Stephen H. Schneider, MD, is the principal investigator for the study. For more
information about the study, call Shelley Greenhaus, RN, at 732-235-7751.
COMPILED BY MAMIE HARGROVE
Winter
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