Welcome to the American Osteopathic Academy of Addiction Medicine's Essentials in Addiction Medicine. This learning management system today will focus on the assessment and management of tobacco use disorders. My name is Dr. Gregory Landy, and I will be your narrator throughout this presentation. I have no financial or ethical disclosures to disclose in this particular presentation. And so with that said, let's begin. During this presentation, we will begin with the review of the diagnostic criteria for a tobacco use disorder as described in DSM-5. We'll then spend a few minutes talking about the history of tobacco. This fascinating discussion will set the stage for a clinical discussion that follows. It's important to understand the epidemiology of tobacco, and so we will spend a few minutes looking at the impact of tobacco use disorders on health care in general. This presentation will also review a common assessment instrument that you can use in your clinical practice that will help you identify the level of nicotine dependence that an individual may have. We'll learn about behavioral change as a strategy that may help in the management of tobacco use disorders among your patients. And finally, we'll talk about some of the more common forms of treatment that you can discuss with your patients. Among his many discoveries, Columbus is credited with introducing tobacco to Europe in the 15th century. So as the story goes, Jerez and Torres were two intrepid sailors that accompanied Columbus on one of his journeys, and they are credited with being the first Europeans to actually smoke tobacco. Both Jerez and Torres apparently observed that the natives, on one of their shore excursions, had wrapped dried tobacco leaves in palm leaves or corn leaves, and then in the manner of a musket, as they described it, formed from that material. They would then light one end, and they commenced drinking, as Jerez and Torres would later describe it, the smoke through the other end of their paper cone. Now, Jerez became a confirmed smoker when he returned back to his native land, and he is thought to be the first of many that would follow outside of the Americas. Now when he brought this habit back to his hometown, the smoke that billowed from his mouth and nose so frightened his neighbors that he was imprisoned by the Holy Inquisitors, and he remained in the hapless condition for seven years. By the time he was released, smoking was a Spanish craze. Sir Francis Drake helped popularize smoking in Spain, and he later introduced the habit to Sir Walter Raleigh in England. Now Ralph Lane, who was the first governor of Virginia, was also introduced to the habit by Sir Walter Raleigh, and Lane reciprocated by introducing the long-stemmed clay pipe to his friend. So Lane is credited with inventing the clay pipe that became a staple of smoking. Although Columbus is commonly credited with being the individual who introduced tobacco into Europe, it is a fact that the use of tobacco was known long before Columbus discovered it on one of his journeys. In fact, the first human use of tobacco dates back several millennia, and during that lengthy period of time, humans have used tobacco in just about every imaginable way. In the beginning, the tobacco leaf was most likely chewed. So why is there a teapot on this slide? Well, the next method of consumption was drinking tobacco in a sort of tea. Tobacco leaves were boiled or steeped in water, and what must have been a relatively noxious beverage was then consumed. This was also a popular method of consumption among ancient medicine men. One of the advantages of exploring the history of tobacco, or actually any subject, is that it provides a longitudinal context for what sometimes seems like a modern issue. So on this slide, we see a phrase, and I'll read it. There is no habit to which we are given that sits so vilely on us and shows our selfishness as a people as is perpetual smoking, chewing, and spitting. It is a minority of the people who use tobacco, and we cannot see any argument that can be cited to show their right to annoy and disgust the majority with the results of their bad habits. Now clearly, these words could have been written in the last many decades, but in actuality, this came from an editorial in Frank Leslie's popular illustrated newspaper from 18 November, 1858. Smoking and military service often seem synonymous. Even a casual glance at the magazines and newspapers of the years gone by shows the prevalence of advertising and the number of ads that featured military service members, just as this particular advertisement shows. So what was the effect of all this? By 1944, cigarette production was up to 300 billion cigarettes a year. That's right, 300 billion cigarettes a year. Now, servicemen received about 75% of all cigarettes that were produced in that year. And interestingly enough, the Second World War's sharp increase in the demand, or perhaps issuance of cigarettes, caused a scarcity of the tobacco leaf. This brought about a worldwide shortage, and that situation was not corrected until the early 1950s. So with that brief introduction to the history of tobacco, let's move on to a clinical discussion, and that would naturally begin with the diagnostic criteria as described in DSM-5. The proper word is tobacco use disorder, and according to DSM-5, there are three criteria with their associated sub-features. It's also important to note that the definition requires the use of tobacco products over a one-year period, and that has resulted in at least two of the following 11 sub-features. So let's go over this slide in a little bit of detail. So the three criterion are listed by the A, B, and C. A, larger quantities of tobacco are used over a longer period than intended. B, there's tolerance for nicotine. And C, there are withdrawal symptoms upon cessation of use. Now the larger quantities of tobacco use over a longer period of time have the eight associated sub-features. Again, of the 11, you need at least two. Tolerance for nicotine has only need for increasingly larger doses of nicotine in order to obtain the desired effect and or a noticeably diminished effect from using the same amounts of nicotine. And withdrawal symptoms are manifested by two sub-features, the onset of typical nicotine associated withdrawal symptoms, and more nicotine or substituted drug is taken to alleviate the withdrawal symptoms. Again, let's keep in mind that a tobacco use disorder diagnosis has three criterion with 11 associated sub-features, two of which at a minimum must have been present over the preceding one year. Perhaps at this point you're asking yourself, why is the American Osteopathic Academy of Addiction Medicine devoting an entire presentation to tobacco use disorders? Well perhaps this slide will help explain that. Tobacco use remains the number one preventable cause of disease, disability, and death in the United States. As a consequence, clinicians should be aware of tobacco use disorders and be on alert for screening tobacco use disorders among their patients. It's estimated that more than half a million Americans die prematurely from tobacco use and another 16 million suffer from a disease caused by smoking. Although the numbers fluctuate, approximately 42 million United States adults currently smoke cigarettes, and secondhand smoke exposure also causes serious disease and death. The CDC suggests that primarily because of exposure to secondhand smoke, an estimated 7,000 non-smoking Americans die of lung cancer and more than 33,000 die of heart disease as a result of secondhand smoke exposure. And if that's not enough, the health care costs attributable to smoking and secondhand exposure are around $300 billion annually. The purpose of this slide is to show what results from a concerted effort to address a public health problem. As I mentioned in a previous slide, during World War II and the years after, cigarette consumption was reaching its all-time high, but health concerns were also accompanying that rise. And it was in the 1970s that concerted efforts were being started to address this public health concern. At the top of the peak, you can see the first Surgeon General's report outlining the health consequences of tobacco use disorders, followed a few years later by a ban on the advertisement of tobacco. As we move forward in time through the 80s and 90s, we see that other factors came to bear that reduced the use of tobacco. We have a tax on cigarettes, another Surgeon General's report, followed by other tax increases. This concerted medical, social, legislative action has resulted in a steep decline in the use of tobacco. This slide amplifies our previous discussion about the factors that reduce tobacco use. We have two broad areas, policy interventions and clinical interventions. As was demonstrated in the previous slide, policy interventions included taxation, smoke-free legislation, warning labels placed on cigarettes and other tobacco products, and remember that insurance premiums are higher for individuals who admit to smoking. On clinical interventions, the stage of change-based interventions have been very helpful, which is a core part of motivational interviewing, along with physician advice through brief counseling and other behavioral strategies that help individuals understand the implications of their continued tobacco use and the means available to help them quit. The relationship between a tobacco use disorder and other substance use is an important area. These bilateral relationships offer important clinical insights that can be useful when eliciting histories from your patients. For example, it's been estimated that an 80-90% smoking rate has been found in individuals with a current alcohol use disorder. Heavy smoking is linked with drinking. Interestingly enough, in one study, it was found that 72% of those currently in treatment with an alcohol use disorder were smoking heavily versus 9% in the general population. So what does this tell us? How does this inform our clinical practice? Well, I think it's safe to say that given this bilateral relationship, if we identify an individual with an alcohol use disorder, the probability that they also have a tobacco use disorder is very high and vice versa. Now we find similar results among individuals that are using illicit drugs. And so once again, as part of a comprehensive assessment of a substance use disorder, we need to keep in mind these bilateral relationships. And it goes without saying, although it's been studied extensively, is that among individuals who smoke, they have greater health problems and overall poor treatment response to the various treatments for their physical and emotional problems. So let's elaborate on this relationship a bit more. Among individuals with an alcohol use disorder, these individuals find nicotine more reinforcing and they also will meet more of the tobacco use dependence criteria and they will more likely have significant withdrawal symptoms. Now interestingly enough, based on published research, there is evidence that many people in a substance abuse treatment program are interested in quitting smoking as part of a comprehensive reduction in their use of substances. But even with that in mind, in the medical community, there is continued debate as to the best time to introduce tobacco treatment during other substance use treatments. But what's not in debate, and should not be in debate, is at some point your patient will be offered the opportunity to quit tobacco. There are some incontrovertible clinical findings involving tobacco use among individuals with mental illness. And perhaps the most interesting and common is the prevalence of smoking among individuals with a diagnosis of schizophrenia. It's been estimated that 70 to 90% of such individuals use tobacco. Among individuals with affective disorders, the numbers are a bit lower, but nonetheless significant. And again, hinting at the bilateral relationship between tobacco and mental illness, there is emerging and continuing evidence that affective anxiety and substance use disorders are more common in individuals who smoke than those who have never smoked. Recommendations have a vital role in reducing the economic and health consequences of tobacco use among their patients. And the CDC recommendations that are listed on this slide help in that effort. The CDC recommends that every patient is screened for their tobacco use. And such efforts are documented in their clinical record. Among those individuals that seem to be at risk for a tobacco use disorder, the clinician should offer medication, unless contraindicated, counseling, and assistance, and in those situations which warrant it, a referral. And there are many, many resources for this. The CDC approach has been summarized as the five A's. Ask about tobacco use. Advise the individual to quit. Assess the individual's willingness to stop smoking or using tobacco. Assist in the quit attempt. Be a partner with the patient. And finally, arrange follow-up. It's a sobering fact, but individuals with a tobacco use disorder face a chronic relapsing illness with the course of intermittent episodes alternating with periods of remission. You've probably heard many of your patients say that stopping the use of tobacco is the hardest thing in the world. And these numbers underline that effort. 3% of individuals who quit or try to quit without formal treatment are successful. About 30% of people who want to quit are actually seeking treatment. And the outcomes vary by the type and intensity of treatment that you can offer your patients. Reports of one-year abstinence rates following treatment vary from 15% to 45%. And the relapse curve for smoking parallels that for opioids. And perhaps not surprisingly, most individuals with a tobacco use disorder who are trying to quit will relapse during the first three days of that intense withdrawal. Others will relapse within the first three months. So let's now transition to a discussion of the many techniques in the management of tobacco use disorders. In the broadest sense, we're going to be looking at motivational interviewing plus the various options you have in terms of pharmacotherapy. Education is a key preventive component in the management of tobacco use disorders. Our goal is to identify both individuals at risk of developing a tobacco use disorder and for helping those individuals who have already developed it to quit the use of their tobacco products. We'll go into the stages of changes in a bit more detail in just a second, but keep in mind that when it comes to an individual with a tobacco use disorder, seriously considering quitting smoking, most are in the pre-contemplation and contemplation phase, which means that they are not, for the most part, actively considering giving up their habit. Your role at this particular point in your clinical discussion with the patient is to help them understand the consequences of their tobacco use. It can be many things, from the cost of maintaining the habit to the downsides, such as the lack of energy. They'll get better sleep if they stop using tobacco products. Food will taste better. Their appetite will come back. Again, they're going to save money, and it should never be forgotten that there are serious health consequences attendant to the continued use of tobacco products. So this particular slide is a review of the steps involved in the stages of change. Now, as I mentioned in the previous slide, most of your patients with a tobacco use disorder are going to be in the pre-contemplation phase. So what does that mean to you as a clinician? When you bring up the notion that they are at risk or already have a tobacco use disorder, your patient has no concept of problem and has no plans to change. So at this point, the best you can probably do is to agree to disagree about the presence of their tobacco use disorder. Should briefly discuss the implications, but probably even more importantly, in follow-up visits, you want to, again, bring it up. Where you want your patient is to be in the action phase. Here, they're ready for behavioral change. You are providing strong encouragement and support. You've provided education and assistance with the many treatment options that are available. And you'll be meeting with your patient on a regular basis to help support and monitor and encourage their progress. Just talking with your patient can be so helpful. There's a strong dose relationship between the intensity of their tobacco dependence and the counseling being more effective among this group of individuals. As you might imagine, the most effective treatments would be person-to-person, clinician and patient, although other methods are employed, of course, including group and telemedicine or telephone contacts. These counseling interventions should focus on problem-solving, assessing and providing, where appropriate, social support. And don't forget, there's an abundance of literature supporting that your role as a clinician in providing brief, targeted interventions where you congratulate the patient, encourage them and educate them can have significant impact on their ability to quit tobacco. As is the case with most clinical interventions, a combination of counseling and pharmacotherapy hold the promise of providing the best relief for your patients. And so who should be offered pharmacotherapy? All your patients should be offered pharmacotherapy to help them through the rough spots as they quit tobacco. There are, of course, contraindications. With any medication that you're contemplating, you need to know the medical contraindications. Those smoking fewer than 10 cigarettes a day may or may not be best candidates. Certainly pregnant or breastfeeding women should not be considered at this time. Adolescents and smokeless tobacco users in every situation, despite these exceptions, with the exception of the medical contraindications, always consider the risk-benefit for your patients. Have an informed discussion and remember patient-centered care. Pictured on this slide is a Fagerstrom tolerance questionnaire. It's a very simple validating instrument that can help you and your patient determine the extent to which they may be dependent on the nicotine, which is found in their tobacco products. The Fagerstrom tolerance questionnaire is also used to help gauge nicotine replacement therapy. So it's a useful tool to have in your clinical armamentarium. As you can see, it only requires eight questions, and so the burden on your patient is minimal. But the clinical impact can be significant. As you see, if the patient scores between 7 and 14, they're considered very dependent on nicotine. So consider this slide as a common overview, information all in one slide, of some common nicotine replacement therapies. As you can see in this particular table, nicotine gum, patch, nasal spray, and the oral inhaler are all looked at in terms of their availability, flexible dosing schedules, whether or not they involve behavioral extinctions, their speed of onset, the frequency with which they can be used, the effort required for proper use, whether or not it mimics the behavioral aspects of smoking, and what are the primary side effects. So again, this slide is simply offered as a go-to to get an idea of what are some of the common nicotine replacement therapies and their comparisons. So in terms of medication management, we have three product areas that are FDA approved. We have nicotine replacement, which are considered agonist therapies, such as nicotine gum, the lozenge, the patch, nasal spray, and the inhaler. We also have bupropion, which of course is also approved for the treatment of depression and, for purposes of this discussion, smoking cessation. And finally, we have varinicline, which is a nicotine partial agonist. The nicotine inhaler is an FDA approved nicotine replacement therapy. It's an agonist therapy, available by prescription only. The nicotine inhaler consists of a plastic cylinder containing a cartridge that delivers nicotine when you puff on it. It's important that you as a clinician remember and advise your patient that this is not a pulmonary effect. They are not truly inhaling the product. They are puffing on it. The nicotine is delivered into the mouth, not the lung. And because it enters the body in that manner, it's much more slowly absorbed than the nicotine in cigarettes, which of course are delivered through the lungs. Recommended dose is 6 to 16 cartridges per day. Each cartridge has 4 milligrams of nicotine in it. That occurs if the individual does 80 puffs over roughly 20 minutes. The recommended duration of therapy with the nicotine inhaler is 12 weeks, but can be longer, up to six months. And one of the purported advantages of the nicotine inhaler is that it satisfies the pleasure or the behavioral aspects of having the cigarette in the mouth. The nicotine nasal spray, also FDA approved, also nicotine replacement, and of course an agonist therapy. The advantages of the nicotine nasal spray is its rapid delivery of one milligram of nicotine, which not too dissimilar from smoking cigarettes, produces a peak nicotine blood level in 10 minutes. So the nicotine nasal spray has some value in the rapid relief of withdrawal and craving. One to two doses per hour, minimum of eight per day, maximum of 40 per day, and three to six months of use. If you're choosing the nicotine nasal spray after discussion and concurrence with your patient, there's some further consideration to keep in mind. The nicotine nasal spray has side effects, such as throat irritation, coughing, sneezing, may cause the patient to tear up. And of course, you can't use it if the individual has an upper airway disease. It should be reserved for those who fill nicotine gum and or a patch. And it's also important to keep in mind that of the nicotine replacement therapies, it has the highest potential for dependence, as indicated by the fact that 15% to 20% of individuals using the nicotine nasal spray will use it longer than recommended. Nicotine gum is a popular choice. It's FDA approved. And again, it's an agonist therapy. Nicotine gum can reduce the nicotine withdrawal and the associated symptoms. But its effect on craving is minimal. There are two and four milligram products that are used over a 30 minute period. The four milligram dose should be reserved for heavy smokers. Again, that can be defined as 25 cigarettes a day, or as mentioned previously, perhaps even better, is used in nicotine Figerstrom scale. So nicotine gum is used differently than regular chewing gum. It's parked between the buccal mucosa and sits there. And that's where it's absorbed. P concentrations are achieved in 15 to 30 minutes, which is the explanation for why it has minimal impact on craving. It's much, much slower than the peak concentration achieved with the cigarette. It's important when using nicotine gum to remind your patient to avoid acidic foods and beverages. They'll have to give up their coffee and their juices and their soft drinks when they've got the nicotine gum in their mouth, as that will decrease the absorption of the nicotine. And from the standpoint of pregnancy, nicotine gum is classified as a class D. While risk has been shown to the fetus, the use could be justified in some cases. Of course, again, this requires a careful, informed consent and documentation that balances the risks and the benefits with the patient's choices. It's always useful to have some idea about how long a particular treatment lasts, its cost, and its success rate. And this particular slide gives some indication of that. The length of treatment for the nicotine gum, up to 12 weeks. And although the costs change and vary, those listed on the slide give you some idea. But perhaps more importantly, what is the success of using nicotine replacement therapies? Well, quit rates can be increased by 50 to 70%, and almost 7% will achieve a sustained abstinence at the six month mark. Nicotine lozenges offer another choice for nicotine replacement therapy. These FDA approved lozenges are available in two and four milligram dose drinks. Four milligram for those who smoke within 30 minutes after awakening. Again, remember the Fagerstrom scale can be useful in assessing the degree of nicotine dependence. A typical dosing schedule would be one lozenge every one to two hours during the first six weeks of treatment, using a minimum of nine lozenges a day. You would then decrease lozenge use and decrease lozenge use to one lozenge every two to four hours during week seven to nine. And then decrease one lozenge every 48 hours during weeks 10 to 12. So of course this dosing regimen does require compliance for patient adherence. One of the more popular choices for nicotine replacement therapy is the transdermal nicotine patch. A 24 hour patch delivers 21 milligrams of nicotine and peak level six to 10 hours after application. The length of treatment, eight weeks. And a typical treatment course, although there are other possibilities here, might be four weeks of the 21 milligram for 24 hours. Then two weeks at 14 milligram patch for 24 hours. And two weeks with a seven milligram patch over a 24 hour period. The transdermal nicotine patch can cause some local irritation, mild gastric, or it can interfere with an individual's sleep. Again, this slide gives some indication in general terms about the effectiveness and the cost of the transdermal nicotine patch. At the end of a course of treatment, smoking quit rates can range from 18 to 77%. Six month abstinence rates can vary between 22 and 42%. You can use the patch and gum together. Again, taking into account the patient's healthcare status and their preferences. And any contraindications. Although again, costs can vary. This gives you some idea of what this particular treatment will cost. Bupropion is another choice to offer your patients who are interested in quitting tobacco. There are certain factors that increase the success rate. Higher doses of bupropion, being male, and among individuals that have had lengthy periods of abstinence in the past. Now, if we look at some studies about quit rates comparing the various pharmacotherapies, we see that if we use a placebo, we can get a 20% quit rate. The transdermal nicotine patch, the 21 milligram version, can have a 32% quit rate. Bupropion SR, 150 milligrams BID, can have a 46% quit rate. And bupropion combined with the transdermal nicotine patch can have a 51% quit rate. Of course, these numbers vary with various research studies, but it gives you a general idea. Again, bupropion is FDA approved. It's an interesting medication that's both dopaminergic and noradrenergic. For those individuals where you're targeting tobacco use, the initial dose, 150 milligrams of the SR daily, and then increase to 300 milligrams. Treatment, again, up to 12 weeks, up to six months. Among the side effects, dry mouth, insomnia, and of course, bupropion can cause some activation. You don't want to use bupropion in patients with a history of seizures or bulimia or bipolar disorder. There are other side effects associated with bupropion. So you'll want to go over these with your patients as part of the informed consent process. Barenicline is another FDA approved option for helping your patients quit the use of tobacco. This product is a nicotinic acetylcholine receptor partial agonist that decreases an individual's desire for craving to smoke. The medication is tapered as part of its approach. And barenicline should be taken after eating and with a full glass of water to minimize the side effects. Patients should be treated for 12 weeks. And for those patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks is recommended to further increase the likelihood of long-term abstinence. The maximum is six months use. Barenicline requires some additional considerations. Monitor for depression, agitation, and suicidal thinking through the course of treatment. The common side effect is nausea. Again, making sure your patient takes the medication with a full glass of water will help reduce that. And obviously, in consideration of the need for monitoring of emotional symptoms, you should get a psychiatric history prior to prescribing this medication. And if the individual has significant neuropsychiatric symptoms, you'll wanna do a careful informed consent and determine if it's appropriate to either start the medication or if medication has been started. Discontinue it if the symptoms worsen. And you see on this slide the approximate cause of use. We've now come to the end of this presentation on tobacco use disorders, their assessment and management. And so let's do a brief summary. We reviewed the diagnostic criteria for tobacco use disorders in the Diagnostic and Statistical Manual. We learned about the history of tobacco. We looked at the epidemiological impact of tobacco use on healthcare in America. We looked at the Fagerstrom Assessment Instrument as a way to gauge nicotine dependence. We learned about behavioral change, motivational interviewing, and the stages of change. And we understood the more common forms of treatment, which included counseling and pharmacotherapy. So as we conclude this presentation, again, I'm Dr. Gregory Landy. And on behalf of the American Osteopathic Academy of Addiction Medicine, let me thank you for taking time to take part in our learning management system.

tobacco use disorders

DSM-5

assessment

management

nicotine dependence

behavioral change strategies

counseling

pharmacotherapy