Frequently Asked Questions
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The Nicotine Patch
Q: What is the nicotine skin patch?
A: The nicotine skin patch is one nicotine replacement product available over the counter to relieve some of the withdrawal symptoms people experience when they quit smoking. The nicotine patch was approved by the Food and Drug Administration (FDA) in 1991.
Q: How does the patch work?
A: The patch provides a constant amount of nicotine in your body; the nicotine dissolves right through the skin and enters the body. The patch can relieve some of the physical symptoms associated with quitting smoking so you can concentrate on your behavioral and psychological addiction to cigarettes.
Q: What does the patch look like?
A: The patches look like Band-Aids, but they come in different sizes and shapes. The larger the patch is, the more nicotine it delivers through the skin. You will start on 21 mg for the first 2 weeks, then you will switch to a medium strength patch of 14 mg on the third week, and to the lower strength of 7 mg during the fourth week.
Q: How do I use the skin patch?
A: It’s very simple. Follow the instructions that will be given to you along with your patches. Starting on your quit date (session 3), apply a patch once a day to a non-hairy, clean, dry area of your upper body (this includes the outside of the upper part of each arm). Press the patch firmly onto your skin. It should stick to the skin well, and allow you to do all of your usual activities (including bathing). Each day you will put on a fresh patch. When you remove the patch, put the fresh one on a new area of your upper body. Do not reuse a skin area for at least one week.
Q: Isn’t the patch just as bad for me as smoking cigarettes?
A: No, because you get less nicotine through the patch than you do with cigarettes. Also, the patch does not have the tars and poisonous gases that are found in cigarettes.
Q: Aren’t you just trading one addiction for another?
A: No. Although it is a common belief that the patch is just as addictive as cigarettes, this is false. Cigarettes are particularly addictive because they cause peaks and jolts of nicotine within the body (nicotine reaches the brain in 9 seconds). The patch gives you steady levels of nicotine at a medium to low level so there are no jolts in your brain. Studies have shown that people do not get addicted to the patch because of this slow release and also because chemicals in cigarettes that “boost” the pleasure of smoking are not present in the patch.
Q: Will it be hard to give up the nicotine patch?
A: Studies have shown that it is much easier to give up the patch than it would be to give up cigarettes, for two reasons. First, we usually develop cravings for things that provide immediate satisfaction, like chocolate. With the patch, the nicotine level in your body stays relatively constant day after day. There is no immediate satisfaction, so there is little craving for a patch. Secondly, anything you do often such as smoking becomes a habit. Since you only put on the patch once a day, there is no strong habit to break.
Q: I’ve heard that some people have had side effects from using the patch. Is it dangerous to use the patch?
A: You can overdose on nicotine, so it is critical to follow the instructions on how to use the patch. Do remember that nicotine patches contain a strong drug. Keep the patch away from children and pets. Do not put on more than one patch at a time.
Make sure that you quit smoking completely before starting to use the patch. You should never smoke a cigarette while using the patch. If you do slip and smoke a cigarette while wearing the patch, contact Study Coordinator, Mihai Raicu, or your therapist if severe side effects occur. Some side effects from wearing the patch can include headaches, dizziness, upset stomach, diarrhea, weakness, blurred vision, and vivid dreams, which may result from an interrupted sleep pattern when you quit smoking. Some people report a mild itching or burning on the skin. This usually goes away in about an hour. If the irritation continues, you can try moving the patch to a different spot. If it persists, remove the patch and contact Mihai or your therapist.
Q: Is it worth these risks to use the patch?
A: You need to decide. If you use the patch correctly, you can double your chances of quitting smoking.
Q: I’m wearing the patch, but I still crave cigarettes sometimes. Is this normal?
A: When you wear the patch, you are less likely to suffer from several of the major smoking withdrawal symptoms such as tenseness, irritability, feeling sleepy and having a hard time concentrating. Cravings may not last with the patch, but do not expect them to disappear magically. For most smokers, there is more than one reason why they smoke. Nicotine addiction is just one part of the habit. We also develop a behavioral or psychological addiction as well. Certain feelings, times of the day or activities all become strong cues and make us crave a cigarette. This program will address these issues, and more. That is why it is so important for you to participate in all of the therapy sessions.
The Study Drug
Q: What is the study drug?
A: The study drug is a prescription drug we are examining in our smoking cessation study. It has been approved by the Food and Drug Administration (FDA) for the treatment of other addictions, including alcohol and opiate dependence. Some of our prior data show that it may help people quit smoking by reducing the urge to smoke. As with all medications for addictions, it is recommended that the study drug be used in conjunction with a counseling program.
Q: How should I take the study drug?
A: You should take a quarter pill (12.5 mg) once in the morning for one day. Then for the next two days you should take a half pill (25 mg). On the morning of the 4th day begin taking one whole 50 mg pill. Continue taking one whole pill (50 mg) in the morning each day leading up to your quit day and continue taking the drug for the next 12 weeks.
Never take an “extra” dose of the study drug . If you forget to take a dose, do
not take an extra tablet to “catch up” for the dose you forgot. Instead, wait and take your next tablet at the regular time. Do not take more tablets than the doctor has prescribed. This is important so you do not increase your chance of harming your liver.
Q: What do I do if I skip a dose? What do I do if I have leftover pills?
A: Please return all unused tablets each week when you are provided with your next supply of tablets. Please be honest with the research assistant about how many tablets you took during the previous week.
Q: Can I smoke while taking the study drug?
A: It is not physically dangerous to smoke and use the study drug at the same time. However, it is important to make an effort to quit smoking on the quit date established with your counselor. This will increase your chances of breaking your smoking habit. You will begin taking the study drug while you are still smoking, since several days may be needed to achieve a level of the study drug in your body that is effective and helpful.
Q: Why is the study drug used at the same time as nicotine patches?
A: For the purposes of the study, we would like to find out about the effects of the study drug when added to patch treatment and counseling. While nicotine patches have been found to reduce the severity of withdrawal symptoms, it may not help with urges to smoke in some situations. That is where we believe the study drug will be helpful.
Q: What are possible side effects of the study drug?
A: Like all drugs, the study drug may cause side effects. The most common side effects include headaches, nausea, and fatigue. These side effects are generally mild and often disappear after a few weeks. If you have difficulty with some of these effects, begin taking the study drug midday (after lunch) or in the evenings, before you go to sleep.
The most common side effects that caused people to stop taking the study drug during clinical studies were nausea and headaches. These occur in only 5-10% of people. Other side effects that people have experienced include: anxiety, increased erections, sedation, agitation, insomnia, rash, anorexia, constipation, dizziness, abdominal pain, and liver dysfunction.
Q: What are possible withdrawal symptoms from quitting smoking?
A: You may experience any of the following withdrawal symptoms from quitting smoking: mood changes, anxiety, irritability, decreased concentration, restlessness, unusual hunger, trouble sleeping, and constipation. Some people also gain weight after stopping smoking. Withdrawal symptoms are common but usually only last a couple of weeks.
Q: Will the study drug affect other medicines I am taking?
A: The study drug may affect other medicines you are taking. It is important not to take medications that act on the opioid system, such as morphine, codeine, vicodin, percocet, etc. The study drug may interact with those medications and may make them less effective. You should make sure that we know about all medicines—prescription or over-the-counter—you are taking or plan to take. Finally, if you are in an accident or injury, please tell a doctor that you may be taking the study drug before a doctor prescribes anything, and then make sure to call the study physician, Dr. Tracie Wilcox, M.D.
Q: How should I store the study drug?
A: Store the study drug at room temperature and out of direct sunlight. Keep the study drug in a tightly closed container, out of the reach of children. Do not give your pills to anyone else to consume.
Q: What should I do if I have a question or a problem?
A: If you have questions about the study drug, or if you experience any disturbing side effects during the study, inform Andrea King, Ph.D., (Principal Investigator) or Tracie Wilcox, M.D. (Study Physician). The emergency numbers are listed on your emergency contact sheet or emergency contact information card.
