Smoking Study: Smoking Cessation and the Effects of Varenicline

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Smoking Study:  Smoking Cessation and the Effects of Varenicline




Guest:  Dr. Karen Hartwell - Psychiatry & Behavioral Sciences, MUSC

Host:  Dr. Linda Austin – Psychiatry, MUSC


Dr. Linda Austin:  Dr. Karen Hartwell is a psychiatrist and Assistant Professor of Psychiatry, with specialty training in a very important area; addiction psychiatry.  Dr. Hartwell, how did you get interested in addiction psychiatry?


Dr. Karen Hartwell:  One of the main things that led me to going into addiction is being aware that people with substance abuse disorders and various types of mental illness smoke at higher rates than other populations.  And, I was keenly aware of many of my patients continuing to smoke even when they were in recovery, even when we got the mental illness stabilized, and then go on to diet complications from their ongoing smoking, or have serious health-related problems.


Dr. Linda Austin:  So, that inspired you.  You are very involved in clinical work, I’m sure, and research.


Dr. Karen Hartwell:  Yes.


Dr. Linda Austin:  In this podcast, we’re going to focus one particular clinical trial that you are recruiting subjects for.  And then we’ll do another podcast on a second one.  Tell us about this trial, Dr. Hartwell.


Dr. Karen Hartwell:  All of my studies involve neuroimaging, which gives us the opportunity to look at the areas of the brain that are activated when people are involved in certain activities.  We know that craving is a key feature of many addictions, including smoking, and is one of the reasons that many people relapse after they try to stop.  In fact, right now, an unaided quit attempt, only, probably, about five percent of people are able to successfully quit.


Dr. Linda Austin:  Dr. Hartwell, when you say an unaided attempt, what you mean by that?


Dr. Karen Hartwell:  Just trying to, cold turkey, quit on your own.


Dr. Linda Austin:  In other words, not using a medication?


Dr. Karen Hartwell:  Right.


Dr. Linda Austin:  Not using any kind of support system?


Dr. Karen Hartwell:  Right.  And, even our most effective treatments to date, probably, at best, about a third of people are able to quit.  So, you can see, there’s lots of room for improvement.  And, craving is one of those big features.  So, with this study, we’re using the medication Varenicline; the trade name of which is Chantix, for those of you who may have seen some of the advertisements in magazines and television.  We’re looking at the effects of Varenicline on changes in the brain in response to craving.


Dr. Linda Austin:  So, if somebody wanted to be a participant in this trial, what would they do, and what would the process be?  What would you actually be studying them for?


Dr. Karen Hartwell:  You would have to be able to undergo an MRI scan.  And, because we use a magnetic field, opposed to radiation, anybody that has certain types of metal, of course, could not go into the scanner.  So, you have to meet certain criteria in terms of being able to have an MRI scan.  And then we would screen you for general good health.  So, we would have you call our study office.  We would screen you over the phone.  Then, we would schedule you to come in for an initial assessment, which would include some questionnaires; a psychiatric assessment.  We would do a physical exam, and then schedule back on another day and get fasting lab work and an EKG. 


Assuming all of that looks good, we would then have you smoke as usual.  We would do the first scan with people smoking as usual, after about two hours of abstinence.  So, we would ask you not to smoke for two hours.  Then, after you have that scanning session, we would start you on the medication Varenicline.  And, that medication, we gradually increase it over the first week.  And then we would have you set your target quit date after about a week after you start the medication.  We would see you, then, weekly for counseling, in combination with the medication.  And then, hopefully, by that point, you’ve been able to quit.  And then we would bring you back to the scanner and repeat the scanning session.  Assuming all goes well, we would see you two more times.  A typical course of Varenicline is three months. 


Dr. Linda Austin:  Now, is there a placebo arm in this?  That is, will some patients be getting a dummy medication, or sugar pill?


Dr. Karen Hartwell:  None of the people in this study will be getting placebo.  This is an open label trial.  So, everybody will know what they’re on.  You’ll know, and I’ll know.  And if we need to adjust the medication for side effects, and those kinds of things, we can do that.  But, on the whole, Varenicline has been fairly well-tolerated in our trials.


Dr. Linda Austin:  So, it’s really a wonderful opportunity for somebody who wants to quit smoking.  They can get excellent treatment.  It sounds like a fantastic physical exam and workup.  And they contribute to science at the same time.


Dr. Karen Hartwell:  Yes.  And one other really nice little side note in this trial is, we’re very interested in looking at the effects of smoking on metabolism.  Many people are very concerned about whether or not they’ll gain weight when they quit.  So, we are fortunate enough, at MUSC, in our Clinical Translational Research Center, to have state of the art measurements of metabolism, using a device called a Bod Pod.  It looks like a giant egg.  You sit in it, in a bathing suit.  And then we can tell you exactly what your metabolic rate is, percent of lean body mass, percent of fat. 

So, we can look at the difference in your metabolism while you’re smoking, and then, hopefully, after you quit. 


Dr. Linda Austin:  Very interesting.  Now, certainly neuroimaging has been a very fertile field of research.  And, for everybody who loves science, and medical science, it’s very exciting to see what happens in the brain.  But, are there practical benefits to having medical scientists understand what happens to the craving centers of the brain?  How will that, potentially, for example, lead to treatment, or help in treatment?


Dr. Karen Hartwell:  Well, I hope that we’ll be able to begin to look at what medications, or interventions, are the most effective in helping people cope with cravings.  So, we’re very hopeful that this is going to lead to more effective interventions, both with medications and feedback, and, also, with psychosocial intervention.  So, we’re really excited about being able to look at what, exactly, is happening in the brain while we we’re asking people to do certain types of treatments and interventions.


Dr. Linda Austin:  Dr. Hartwell, how many subjects are you looking for, for this trial?


Dr. Karen Hartwell:  This trial is 20.  We’re looking for ten men and ten women.


Dr. Linda Austin:  Between the ages, of?


Dr. Karen Hartwell:  Over the age of 21 and under the age of 60.


Dr. Linda Austin:  And, if somebody would like to be evaluated for participation, is there a number that they could call?


Dr. Karen Hartwell:  Yes, there is.  We would ask you to call our research assistant on this project.  Her name is Harvey.  Harvey’s phone number is: (843) 792-8938, and you’d be welcome to call us for additional information and questions.


Dr. Linda Austin:  Dr. Hartwell, it sounds fascinating.  Good luck with the study.


Dr. Karen Hartwell:  Thank you so much.

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