Clinical Trials
Call for Volunteers
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Type II Diabetes
Physicians at UMDNJ-Robert Wood Johnson Medical School in New Brunswick are conducting a research study of a new investigational medication for Type II diabetes. To qualify, participants must be between the ages of 18 and 78, have Type II diabetes and have been taking metformin (glucophage) for at least three months. Participants will receive all study-related care and study medication at no cost.
Stephen H. Schneider, MD, is the principal investigator. For more information call Shelley Greenhaus, RN, at 732-235-7751.
Quit Smoking
Smokers age 18 or older are needed to participate in a clinical study to stop smoking. Volunteers who suffer from cancer, heart disease, lung disease, diabetes, high blood pressure or cholesterol, circulation problems, cataracts, acid reflux, ulcers, osteoporosis, abnormal Pap tests or erectile dysfunction may be eligible to participate in the study. All medications are FDA approved and will be provided at no cost.
Michael Steinberg, MD, MPH, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, is the principal investigator. For more information call 732-235-7149.
Discuss Your Smoking
Smokers age 18 or older are needed for a study being conducted at UMDNJ-Robert Wood Johnson Medical School in New Brunswick. Volunteers must have one or more of the following conditions: cancer, heart disease, lung disease, diabetes, high blood pressure or cholesterol, circulation problems, cataracts, acid reflux, ulcers, osteoporosis, abnormal Pap tests or erectile dysfunction. Volunteers do not need to want to quit smoking, but should be willing to discuss their smoking.
Participants will be asked to meet for one hour and have a 20-minute telephone follow-up. Upon completion of the study, they will receive a $25 gift card.
Michael Steinberg, MD, MPH, RWJMS, New Brunswick, is the principal investigator. For more information call 732-235-7149.
Childhood Autism
The Division of Child and Adolescent Psychiatry at UMDNJ-Robert Wood Johnson Medical School in Piscataway is conducting two (an 8-week and a 12-week) clinical drug studies on autism. The goal of the studies is to explore treatment options for children between the ages of 5 and 17 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 732-235-5690.
Air Pollutants
Non-smokers between the ages of 18 and 45 with no serious medical conditions are needed to participate in research studies on the health effects of diesel exhaust, stress and other air pollutants at the Environmental & Occupational Health Sciences Institute in Piscataway. The studies involve a medical examination and some or all of the following:
- completion of questionnaires;
- blood samples;
- nasal washings;
- collection of mucus from the lung;
- seven visits or less.
Participants will receive as much as $400 compensation at completion of studies.
Nancy Fiedler, PhD, and Howard Kipen, MD, MPH, are the principal investigators. For additional information call Joyce at 732-445-0123, ext. 661.
Environmental Health Research Study
Volunteers are needed to participate in an environmental health research study to compare two measurements of blood vessel function at the Environmental & Occupational Health Sciences Institute in Piscataway. To be eligible, volunteers must be non-smokers and between the ages of 18 and 45. They must participate in measures of arm blood vessel function using sound wave pictures vs. finger pulse pressure recording. They must be willing to take part in three or less one to three hour appointments, scheduled on the Busch campus. Upon completion of the study, participants will receive compensation up to $150.
Howard Kipen, MD, MPH, is the principal investigator. To schedule an appointment, contact Sampada Gandhi at 732-445-0123, ext. 623.
Breast Cancer Prevention
The Preventive Cardiology Program at UMDNJ-New Jersey Medical School is
conducting a research study called ExCel, sponsored by the National Cancer Institute of Canada Clinical Trials Group. The goal of the study is to evaluate the effect of Exemestane, an FDA approved drug, on women at increased risk for breast cancer. Factors that could increase the risk of developing breast cancer are age, family history, age at first menstrual cycle and at the time of first child’s birth. To be eligible to participate, women must be postmenopausal – age 35 or older if surgical menopause – and at increased risk for developing breast cancer. Participants will receive study-related medical exams, including mammogram and bone mineral density test, and study medication. All study visits will be conducted in the Doctor’s Office Center (DOC), 90 Bergen Street, Suite 4200 in Newark.
Norman L. Lasser, MD, PhD, FAHA, director of the Preventive Cardiology Program, is the principal investigator. For more information call Roberta Silverberg at 973-972-6107.
Cytokines in Sleep
Researchers at UMDNJ-New Jersey Medical School are studying the role of cytokines in sleep in patients with chronic fatigue syndrome (CFS). The three-and-a-half year project is funded by the National Institutes of Health. There is a need for 80 CFS female patients for the study. To qualify, volunteers must be between the ages of 25 and 56. Participants must not take brain-active medications because of the effect on sleep and the immune system. They will be compensated for their participation.
CFS patients will be matched by age and gender with 80 healthy participants. The study requires CFS patients to spend four separate non-consecutive nights in the sleep laboratory. During the second visit, researchers will study CFS patients who have disrupted sleep and participants without sleep disruption by measuring sleep-disrupting cytokines and sleep-producing cytokines through blood specimens. An exercise test will be performed in the afternoon followed by a third night in the sleep lab to analyze how exercise affects cytokines.
Benjamin Natelson, MD, is the principal investigator. For more information call Jennifer FitzGibbons, study coordinator, at 973-972-4800, email fitzgijd@umdnj.edu.
The Vagus Nerve Stimulation in Fibromyalgia Study
AVagus Nerve Stimulation (VNS) in Fibromyalgia (FM) study is being funded by the National Institutes of Health at the UMDNJ-New Jersey Medical School. The purpose of the research study is to learn whether the VNS Therapy™ System is safe to use for people who have very severe FM pain. The vagus nerve begins in the brain; it affects the vocal cords, the acid content of the stomach, the heart, the lungs and other organs. FM is a chronic pain disorder of unknown origin, characterized by diffuse body pain and tenderness. The study team will evaluate whether VNS has changed some of the key symptoms associated with FM. A total of 30 participants will be surgically implanted with the VNS Therapy System and they will be closely monitored for two years.
The proposed pilot study will be an open label, non-randomized, single-arm, longitudinal, single-center study of VNS. Its primary aim is to define the limits of VNS safety and tolerability in patients with severe FM. The secondary aim is to assess the impact of VNS therapy on symptoms of FM (including pain intensity, physical function, mood, and quality of life). The goal is to implant and study 30 FM patients
representative of the spectrum of severe FM patients. Participants will have been inadequately helped by conventional pharmacological FM pain treatments.
Participation in the study requires a full understanding of the study protocol and the risks and benefits of VNS therapy beforehand. The study team will inform and evaluate potential participants in order to protect their health and safety during the participants’ involvement in the pilot study. Most common side effects of VNS tend to be mild in nature and severity, often decreasing over time. They include voice alteration, hoarseness, coughing and sore throat during the brief, programmed stimulation periods. The most common surgical risk associated with implantation is infection at either of the two small incision sites, which occurs in approximately 1% of implanted patients. Due to increased pain sensitivity of individuals with FM, the study staff will closely follow all side effects. Implanted participants will have the ability to turn off the VNS device at any time, if needed. They and their medical providers will have 24-hour access to the study team.
The principal investigator is Gudrun Lange, PhD, of the UMDNJ-Pain and Fatigue Study Center. For more information call 973-972-4800.