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Back To Vidyya 24-Hour Nicotine Patch Helps Smokers Deal With Temptation To Smoke

Data From The 11th World Congress On Tobacco Or Health

Smokers wearing a 21 milligram (mg) nicotine patch 24 hours a day experience superior relief of craving and withdrawal when quitting when compared to smokers wearing a 15 mg patch for 16 hours, according to a study in the August issue of Addiction.

"The 24-hour nicotine patch enabled smokers to control their cravings and some withdrawal symptoms more effectively during their first two weeks of abstinence," says the lead study author Saul Shiffman, Ph.D., professor of psychology at the University of Pittsburgh. "Those first two weeks of quitting are crucial, because during this time symptoms usually are at their peak and relapse is most likely."

The study, supported by a grant from SmithKline Beecham Consumer Healthcare, compared a nicotine patch designed for 24-hour wear with one designed for 16-hour wear for relief of craving and withdrawal, particularly in the morning hours. The patches used in the three-week study were the two brands approved for over-the-counter (OTC) sale in the United States: the 21 mg NicoDerm(R) CQ(R) patch and the 15 mg Nicotrol(R) patch. The 21 mg NicoDerm CQ patch provides a constant supply of nicotine, even while smokers sleep and when they first awaken, which protects them against morning craving. In comparison, the 15 mg Nicotrol patch is recommended for use only during the "waking hours" of the day (hence the 16-hour designation), to mimic the pattern of nicotine intake and clearance smokers experience.

Study Design

In the study, researchers enrolled 244 people aged 18 to 65 who had smoked for at least three years and wanted to quit. All of the participants smoked 15 or more cigarettes daily and suffered from morning cravings. They were randomly assigned to either a 16-hour or 24-hour patch. Participants wore two patches during the day, one active, one placebo, and one patch while sleeping: active for the 24-hour group, placebo for the 16-hour group. They also received moderate behavioral counseling. For a week of baseline and two weeks after quitting, participants used palm top computers known as "patient experience diaries," which were used to capture their experience in real-time, real-world settings. Eight to ten times each day, the patient experience diary prompted participants to assess their current craving and withdrawal symptoms. Participants also used the diary to record episodes of when they felt tempted to smoke. This intensive, real-time evaluation yielded detailed profiles of craving and withdrawal experience, which for the first time enabled sensitive comparison of the two patches. The patient experience diary also prompted participants to apply and remove patches at appropriate times and to confirm that they had done so.

Study Results

Analysis of the study data revealed that the 24-hour NicoDerm CQ patch was more effective in lowering craving intensity and frequency than the 16-hour Nicotrol patch. The 24-hour dosing cut craving intensity substantially vs. dosing with the 16-hour patch (e.g., 2.7 vs. 4.1 in days 1-3 of quitting). Additionally, the 24-hour patch cut at least by one-third the time that participants experienced craving (e.g., 13% vs. 20% of waking hours in days 1-3 of quitting).

"Our study showed that NicoDerm CQ yields better symptom control in the morning when smokers on Nicotrol would have very little nicotine in their bodies. Also, NicoDerm CQ's effects extended throughout the day. NicoDerm CQ's good control of symptoms early in the day could get smokers 'off to a good start,' reducing their craving and withdrawal throughout the day," Shiffman says.

When compared to the 16-hour dosing Nicotrol patch, NicoDerm CQ also helped lower the numbers of temptations smokers experienced (e.g., 2.4 vs. 4.5 over the first 3 days of quitting), while reducing some of the most common withdrawal symptoms many smokers endure, including anxiety, irritability and restlessness.

SmithKline Beecham originated the OTC nicotine replacement therapy category with the FDA approval of over-the-counter Nicorette nicotine gum and continues to lead the market after the introduction of the original over-the-counter NicoDerm CQ nicotine patch and the launch of over-the-counter Nicorette Mint and Clear NicoDerm CQ.


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Editor: Susan K. Boyer, RN
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