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February 16, 2022 ENCORE NewsUncategorized

Jacksonville Center for Clinical Research is Participating in ORCA-3, a Phase 3 Clinical Research Study Evaluating an Investigational Smoking Cessation Therapy

Jacksonville Center for Clinical Research is enrolling eligible volunteers into ORCA-3, a U.S. Phase 3 clinical research study evaluating the safety and efficacy of cytisinicline, an investigational therapy for smoking cessation in adults who smoke ten or more cigarettes per day, intend to quit smoking and have failed at least one previous attempt to stop smoking with or without therapeutic support.

A recent report showed, in 2020, for the first time in twenty years, there was an increase in cigarette purchases[1]. Despite the clearly defined health risks associated with cigarette smoking, it is estimated that there are 34 million adults who are current cigarette smokers.[2] Prescription medication and counseling have been shown to improve quit rates yet are used by a minority of those trying to quit. Among the 68% of smokers who want to quit, less than 7% reported using counseling and only 29% reported using pharmacotherapy, and less than 5% used both.[3]

Cytisinicline is a plant-based, naturally-occurring investigational compound that is structurally similar to nicotine and is believed to aid in smoking cessation by binding more specifically to a certain nicotinic receptor in the brain. This binding partially stimulates dopamine release, which reduces nicotine cravings and the severity of nicotine withdrawal symptoms. It also directly inhibits nicotine binding, reducing the satisfaction typically associated with smoking.

The FDA-approved non-nicotinic smoking cessation therapies, varenicline and bupropion, can improve rates of smoking cessation, but they are associated with troublesome side effects. Additional treatment options are needed if we are to help more people successfully quit smoking and reduce their smoking-related health risks. While the benefits of quitting cigarette smoking are well understood in both the medical and consumer communities, it is encouraged that cigarette smokers make quitting a resolution for 2022 and to speak with their health care providers about options that can help them succeed, including potential clinical trial participation when appropriate.

ORCA-3 is being conducted to learn more about the effectiveness and safety of 3.0 mg cytisinicline for 6 and 12 week study treatment periods in combination with behavioral support in people trying to quit cigarette smoking. The research will also assess the safety and tolerability of the study drug.

Jacksonville Center for Clinical Research is a clinical site participating in ORCA-3. The study is open to adults at least 18 years of age who currently smoke ten or more cigarettes per day, intend to quit smoking, and have failed at least one previous attempt to stop smoking with or without therapeutic support. Participants must be willing to set a quit date within 5-7 days of starting treatment and be willing to actively participate in the study’s smoking cessation behavioral support provided throughout the study.

If you or someone you know is interested in joining the study, please call 904-730-0166

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[1] Cigarette Report for 2020 – ftc.gov. (n.d.). Retrieved November 9, 2021, from https://www.ftc.gov/system/files/documents/reports/federal-trade-commission-cigarette-report-2020-smokeless-tobacco-report-2020/p114508fy20cigarettereport.pdf.

[2] Centers for Disease Control and Prevention. Current Cigarette Smoking Among Adults in the United States. Available at: https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm. Updated November 18, 2019.

[3] Adams AJ and Hudmon KS. Pharmacist prescriptive authority for smoking cessation medications in the United States. J Am Pharm Assoc. 2018;58(3):253-257. doi: 10.1016/j.japh.2017.12.015


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January 18, 2022 BlogUncategorized

Daily habits can be hard to break, and if your daily habit is smoking, it can feel nearly impossible! However, when you understand the addictive nature of tobacco, it’s easier to understand why many just can’t quit. In fact, within the last couple of years, 50% of smokers attempted to quit, but only about 8% were successful. 

Smoking cessation becomes easier if you have a plan in place. Below is a comprehensive list that will aid in your journey to a healthier lifestyle without tobacco. So let’s quit smoking together!

The Plan

1. List your Reasons for Stopping 

Stay motivated by writing down a list of reasons you want to stop smoking. Frequently referring back to this list will keep you aware of why you are doing what you are doing when times get hard. 

Reasons can include:

  • Reducing your risk of heart disease. The risk of heart attack or stroke is decreased by 50% after two years of not smoking. After 15 years, your risk of heart attack is similar to that of a person who never smoked
  • Saving money! Smokers can save between $1,380 and $2,540 annually (depending on where they live) by quitting a pack-a-day habit. 
  • Keeping friends and family away from second-hand smoke. Secondhand smoke causes nearly 34,000 premature deaths from heart disease each year in the United States among nonsmokers.

2. Pick a Quit Day

You control your destiny, so it is your responsibility to pick a quit day. If your quit day is too far out, you may find it hard to keep that motivation. But, on the other hand, you need to give yourself time to prepare. 

Many believe it is best to wean off smoking, but studies have shown that the best results come from picking a day and quitting cold turkey. 

3. Prepare for Your Quit Day

Research has shown that the best results come from counseling and medication for quitting smoking. These things take planning. Here is a list that may help you with that:

  • Talk to your doctor about medications. Some treatments can lessen your craving. It is essential to talk to your doctor and begin one on your quit day. There are also clinical trials where you can receive medications for free with no health insurance needed. 
  • Find a support program. You can also talk to your doctor about support programs. There are many in-person or over-the-phone programs where you can speak with others about your journey.
  • Find helpful online tools and apps. Online tools for creating and implementing a quit plan are available from the National Cancer Institute (https://smokefree.gov/build-your-quit-plan) and the Truth Initiative (www.becomeanex.org/). These websites and apps can increase smoking cessation success.

Other tips include: 

  • Making a list of triggers 
  • Telling your friends and family, you are quitting
  • Cleaning your house of triggers 
  • Getting your teeth professionally cleaned 

4. Make your Quit Day Easier

Your quit day is approaching quickly; let’s prepare a set of rules to follow. 

  • Don’t smoke, not even once
  • Be sure you know how to use your nicotine replacement therapy if you’ve chosen that method.
  • Read your “Reasons for Stopping” list 
  • Drink plenty of water
  • Go for daily walks to stay active 
  • Avoid stressful situations
  • Attend a class or call into a therapy/group session

EXTRA TIP: Find Clinical Trials near You 

There are many reasons to join a clinical trial. First, it is free to join, you do not need insurance, and you may receive a stipend for time and travel. You will also get attentive care from a medical professional with frequent checkups to motivate you to stay on task. Lastly, you will feel good knowing you are improving your health and the health of future generations. For more information on clinical trials for smoking cessation, visit encoredocs.com or call 904-730-1066.

 


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January 4, 2022 Uncategorized

We are launching into the New Year by working our brains! Do you think you know all there is to know about clinical trials? Take the quiz and see! Just by taking the quiz, your Research Ready score will be raised in our system to ensure you are at the top of our list for studies! Select one option for each question and be sure to leave your name and email!

 


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January 1, 2016 BlogUncategorized

As each year comes and goes we seem to go through the same cycle. We end the year by reflecting on what we accomplished (or didn’t) over the course of the past year and how we can improve over the next year. Many of us set specific goals which we call our ‘New Year’s Resolutions’. These goals range from budgeting to personal growth to accomplishing a specific task. One topic we all seem to consider though is improving our own health. One person may try a new fad diet and another may set a goal to start exercising once a week. One thing most people don’t consider is participating in a clinical trial.

 

Why would you make participating in a clinical trial part of your New Year’s Resolution? There are many reasons that participating in a clinical trial can improve your health. In the very least people should consider participating due to the Hawthorne effect. Patients receiving individual care in a trial tend to do better than those not in a trial regardless of whether or not they receive placebo. Also, patients may improve their health by receiving new medications or feeling more compelled to take their medications regularly. The many beneficial effects of participating in a trial can combine to make a real difference!

 

Here at ENCORE we are thankful for the patients that have put their trust in us over the past year. Our patients make us who we are and are an integral part of the ENCORE family. Moving forward into 2017 our New Year’s Resolution is to give our patients their best experience with us yet! Our goal is to help you with your health goals. If there is something we can help you with then we would love to go on that journey with you. Happy New Year!

 


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January 1, 2017 BlogUncategorized

I recently stumbled across the work of Professor John Norcross, the “undisputed” guru on all matters related to New Year’s resolutions. Who knew? I guess a guru may exist for nearly all things. Professor Norcross surveyed and followed a few hundred folks who made New Year’s resolutions and compared them to those who did not commit themselves to goals as the calendar year turned.

Here are a few fun facts from the Professor’s findings:

  1. About 50% of Americans make New Year’s resolutions on any given year and 38% absolutely will not make one in principle (er, they’ve resolved not to resolve);
  2. 25% of resolutions fail within one week;
  3. Older folks have greater difficulty keeping resolutions than younger people – 20-somethings beat 50-somethings for one-year resolution success rates – 39% versus 14%. Of course, success rates were self-reported so we can either conclude that the adage about old dogs and new tricks rings true or that millennials tend to grade on a curve.

We can draw solace from Professor’s Norcross’s most persuasive finding:  those who made New Year’s Resolution were 10 times more likely to change unwanted behaviors than those who didn’t make them. Yes, setting goals works and the New Year, fresh with the feelings of optimism and renewal, seems like the perfect time to make them.

We have an exciting agenda of educational programs called “Learn with the Leaders” that we will highlight throughout the year. In January, we will talk to people about how they can help themselves with autoimmune disease, cholesterol problems, diabetes, and memory loss. Please make an effort to attend these sessions.

Participating in a research study has lots of unintended benefits but perhaps most importantly the benefit of having a team help you stick with a program. Let’s resolve to keep our resolutions this year, or at least double the amount of time until we break them.

– Michael J. Koren, MD FACC CPI FAPCR

 

Reference:  Journal of Clinical Psychology, 58(4), 397-405


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June 6, 2017 BlogUncategorized

THE RESULTS ARE IN! 

We would like to wish a big heartfelt THANK YOU to all our volunteers that participated in this international (PCSK9) high cholesterol study of 1300 volunteers completed in 18 countries.

Jacksonville FL volunteers lead the world in this study with ground breaking results!  Our own CEO Dr. Michael J. Koren was the lead international investigator and lead author on the study. Results published in Jama Cardiology. 

Click here to read the entire article written by our CEO and Principal Investigator Michael Koren, MD

 

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As a proven clinical research organization, we take every precaution to assure the safety of and maximize the value for our research volunteers. Qualified doctors, nurses and study coordinators on staff provide support and care throughout the research trial. Participation is always voluntary. We appreciate the time and effort that research volunteers bring to this important process.

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