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The Catalyst

Project Quit tests medication to help teens stop smoking

By Mikie Hayes
Public Relations

Members of the Project Quit team include Dr. Mike Saladin, seated from left, Dr.  Kevin Gray. Standing left to right, Danielle Paquette, Priscilla Muldrow, Dr. Amanda Roper, Jessica Hinton, Christine Horne, Dr. A. Lee Lewis, Dr. Matthew Carpenter, Lori Ann Ueberroth, Dr. Erin McClure. photos provided

“Welcome to Fight Club. The first rule of Fight Club is: You do not talk about Fight Club.”  

This memorable line, made famous by Brad Pitt playing Tyler Durden in the 1999 cult classic “Fight Club,” was but one of many movies where his charismatic, bigger–than–life characters made smoking look enticing and cool.

Young men wanted desperately to be like Durden: powerful, persuasive, and rebellious and if smoking a cigarette helped build that persona, so be it.

Understandably, Pitt and other high–profile actors have been criticized for “glamorizing” smoking in their movie roles. Why does it matter? Research has proved there is a direct correlation between students 10–19 years old lighting up if their favorite stars smoke on screen.

The reason this statistic is so significant is that the habit of smoking is almost universally established during adolescence. Nearly 90 percent of smokers started smoking by the age of 18 and 99 percent started by the age of 26.

Even with all the anti–smoking campaigns and efforts to stop tobacco companies from targeting kids, each day in the United States, more than 3,200 people younger than 18 years of age smoke their first cigarette, and an estimated 2,100 children and young adults who have been occasional smokers become daily cigarette smokers.

Public health experts continue to sound the alarms that cigarette smoking is the leading cause of preventable death in the United States, meaning that smoking is a habit that if curtailed could lead to better health, longer lives, lower health insurance premiums, even more money in the pockets of former smokers.

It is also the reason the Affordable Care Act focuses on cessation so strongly in its preventive care benefits. The Family Smoking Prevention and Tobacco Control Act, signed into law by President Obama on June 22, 2009, contains several provisions aimed at preventing young people from starting to smoke.

But nicotine is highly addictive, making it extremely difficult for people, especially adolescents, to give up smoking. According to MUSC researcher Kevin M. Gray, M.D., associate professor in the Clinical Neuroscience Division and Youth Division in the Department of Psychiatry and Behavioral Sciences, when nicotine is inhaled, tobacco reaches the smoker's brain within 7 to 10 seconds and once there, it triggers a number of chemical reactions that create feelings of intense pleasure for the smoker.

Temporarily, that is.

As nicotine levels begin to drop in the bloodstream, smokers feel “on edge” and agitated within minutes. This is better known as nicotine withdrawal.

As a psychiatrist, Gray deals every day with these realities and his work heavily focuses on helping adolescents and young adults who struggle with smoking addiction. He knows that without help, only about 1 in 20 young smokers attempting to quit will be successful.

In an effort to provide solutions and help them break this habit before they become lifelong smokers and statistics themselves, he is conducting a research study, Project Quit, to test a medication that could aid young smokers with this addiction.

Project Quit sponsored a booth at the Trident Technical College’s Health Fair in April.

The reality is, because of the long-term consequences of continuing this habit throughout a lifetime, if smoking persists at the current rate among youth in this country, 5.6 million of today’s Americans younger than 18 years of age are projected to die prematurely from a smoking–related illness. This statistic represents nearly 1 in every 13 Americans aged 17 years or younger alive today.

Because they lack maturity and life experience, teens rarely realize that by taking up smoking their chances of developing debilitating and fatal diseases in their lifetimes has dramatically increased. Cancer, heart attacks, heart and lung disease, high blood pressure, stroke and cataracts are common in smokers.

Parents are typically alarmed to find out that 6.7 percent of middle school and 23.3 percent of high school students have used tobacco products. Perhaps the most alarming correlation is the fact that teens who smoke are also more likely to consume alcohol and use illegal drugs.

Further, it is not unusual for parents to be blindsided when they discover their child smokes and not to understand why they would have chosen this habit. Interestingly, one of the strongest predictors for children smoking is if the parents are smokers themselves.

Other culprits include friends exerting peer pressure and encouraging them to try cigarettes; believing that smoking makes them look cool, rebellious or independent; seeing movie and TV stars regularly smoking and wanting to emulate that behavior.

In addition, according to Gray, big tobacco advertising targets teenagers, grooming them to be lifelong customers.

“Cigarette companies shape entire advertising campaigns around the research they have conducted related to what appeals to young people. They purposely portray smokers as cool, attractive people, having fun and living on the edge – images that historically appeal to many teenagers. As a result, teens try smoking and because of the incredibly addictive nature of nicotine, and the brain physiology of adolescents and teens, many get hooked and don’t have the tools, support or ability to quit,” he said.

Young people don’t set out to become lifelong smokers. Smokers in this especially vulnerable age group are often interested in quitting but are rarely successful when making “quit attempts” on their own. Only 5 percent of high school–aged smokers believe they'll still be smoking five years after graduation, but they don't understand how difficult quitting can be. Research has shown that after eight years, 75 percent of those smokers will still be using some form of tobacco.

In light of this, and given the numerous and wide–ranging health benefits of quitting smoking at an earlier age, Gray believes that more evidence–based treatments for adolescent smoking cessation are critically needed.

Surprisingly, there has been little research aimed at this younger population and almost all of it has focused on non–medication approaches, with generally limited results. While well established as a cessation treatment in adult smokers, research trials of medication therapies have not been widely focused on adolescent smokers.

In fact, only six placebo–controlled trials, testing nicotine replacement therapy or bupropion SR, (both FDA-approved for smoking cessation in adults)have been conducted and produced mixed but generally encouraging results.

Kathleen Brady, M.D., Ph.D., associate provost for Clinical and Translational Science and director of the South Carolina Clinical and Translational Research Institute, agreed that much more research must be conducted in order to help this vulnerable population.

“There have been very few studies of smoking cessation treatments in teens and young adults. Information about the most effective treatment strategies in this group of smokers is critical so that the problem can be addressed earlier in the addiction process, before all of the health consequences become apparent. I applaud the efforts of Dr. Gray and Project Quit,” said Brady.

A nicotinic agonist is a drug that mimics the action of nicotine at nicotinic acetylcholine receptors. Gray explained that most recently varenicline, a nicotinic acetylcholine receptor partial agonist, has produced superior cessation results in adults across several randomized trials when compared to a placebo, nicotine replacement therapy and bupropion SR. Gray conjectures that given the striking effectiveness as a smoking cessation treatment in adults, it may be a strong candidate for evaluation in adolescent smokers and consequently has formulated a study to determine if that is indeed the case.

Gray explained, “Varenicline, now FDA approved in adults, binds to nicotine receptors in the brain and parks there. Essentially, the spot is occupied. This reduces cravings and withdrawal symptoms, but does not produce a pleasure or reinforcing sensation like nicotine itself. When a smoker on the medication has a cigarette, the nicotine essentially ‘bounces off’ the already occupied receptor. The smoker thus does not experience the usual nicotine-associated pleasure from the act of smoking and the cigarette essentially loses its control.”

Using dosing recommendations from an adolescent pharmacokinetic study, as well as feasibility and safety information from an adolescent pilot cessation trial, Gray and his research team initiated a randomized, double blind, placebo–controlled trial of varenicline for adolescent smoking cessation, supported by the National Institute on Drug Abuse.  

In this study, participants between the ages of 14 and 21 are randomized to receive either varenicline or a placebo for 12 weeks, with multiple post–treatment follow-up visits for six months. Weekly psychiatric and medical visits, including detailed, rigorous safety and tolerability assessments, are conducted throughout the active treatment period. All participants, regardless of randomization group, receive weekly smoking cessation counseling throughout the 12–week course of active treatment.

Gray believes when the study concludes that it will have filled a critical evidence gap and that it has the potential to significantly advance adolescent smoking cessation treatment. “Whether findings are positive, null or negative,” he said, “this study will be an important contribution to the literature and will have considerable clinical and public health impact.”


May 30, 2014



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