Research & Clinical Trials Print

The research team at Integrative Treatment Centers have been actively involved in medical device and pharmaceutical trials for over a decade. In fact, PRISM Healthcare Foundation was formed as the research and education arm of ITC many years ago. This 501(c) 3, non-profit organization has been recognized by both the State of Colorado and the United States government as a non-profit foundation dedicated to advancement of medical education and clinical research.


What does this mean to me as a patient?  

Maybe not too much, unless you, a family member or friend deals with a painful condition which might be the focus of one of these studies. If you or someone you know has been living with a disease that is being studied by ITC and PRISM Healthcare foundation, someone could benefit from learning about the study and the pros and cons about being involved. We recently completed a clinical trial in collaboration with the Food and Drug Administration (FDA) studying a medical device which treats a variety of migraine-type headaches in people who did not obtain good pain control with medications.


Although Dr. Bennett and his staff have been using Occipital Nerve Root Stimulation (ONS) in the treatment of migraine-type headaches for many years, there are many insurance carriers who will not pay for a specific treatment until it is FDA-approved for this diagnosis. In conjunction with a medical device manufacturer and many other pain specialists around the country, we studied the use and outcomes of many people with this disorder to evaluate if this is a treatment option which decreases the number of times per month that the patient has these terrible headaches and also if ONS can decrease the severity of these headaches if they do happen.


How do I find out if a friend or I can be helped with this type of research for a certain pain disorder?


Speak with Dr. Bennett or call James Hagen, MS, at 303 487-0932, extension 102.

You also can Email Integrative Treatment Centers for more information about Clinical Trials and Research Studies. We will be happy to help you find out about studies that we are doing now or in the near future, and can even find information for you about on-going projects at other pain research centers.


What research studies are currently available at ITC to me or a friend?

Right now, we have 2 studies in which we are currently enrolling new patients. One is a medication study for the FDA and Cephalon Pharma.  We are looking at a new method of administering fentanyl, an opioid preparation for people who experience "break -through pain (BTP). This is the pain that someone experiences in between their current pain medication treatment.


If you currently are taking a narcotic medication for pain, experience times during the day when your pain still comes back, and you have not had a change in your medications in the past month, this could be a study that you might want to look at. Please call our PRISM research office and leave a message for Carolyn Jass, RN/PhD at (303)438-1910. She will call you to discuss this study and answer any questions that you might have.


The research that Dr. Bennett and his team are performing is called the Chemical Coping Study. As you may have experienced or heard, there are many health care providers who are worried about prescribing certain medications for people living with pain. Often there are fears that doctors, nurses and physician assistants have about giving patients certain medications in fear that they could "abuse" them or not use them for the reason that they are given.


There are many narcotic medications that are only approved for people having pain from cancer, but can be very helpful for people who have pain for other reasons. This is called, "non-malignant pain. These medications treat many painful conditions aside from cancer pain very well, but have not been approved by the FDA for this. There are many insurance companies who will not pay for certain medications if the patient does not have cancer.


The treatment of various ailments or symptoms can be decided to be used by a physician. This is called an, "off-label use."  We use different medications such as certain anti-depressant or anti-seizure medications for many pain disorders. Unless these have been approved by the FDA for the use in pain, often times insurance companies will "deny" or refuse to pay for the medicine.


Dr. Bennett and a variety of other physicians, psychologists, physiologists and scientists have developed a tool that will help health care professionals predict when a "controlled substance" which might have the chance of being overused or abused by certain individuals.


The hope in studying this tool is that physicians and other providers will be able to predict when the use of narcotics or other medicines would be a good idea or when they should possibly not use them in certain people. Hopefully once this simple set of questions has been "validated," we will be able to offer this to doctors and nurses to be able to better judge when narcotics or other medicines are probably safe to use for certain patients.


We are at the final phase of this research and are looking for about 100 more people who have used narcotics in the past or at this time to participate in this study. If you are someone you know is using pain medication , does not have cancer or use a stimulator or medication pump, has not had their medication or dosage changed in the past month, and would be interested in being part of this important research, please call us or stop by our office.


There is a small monetary payment for your time that is paid at the finish of your hour's participation.

 
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