Nicotine replacement therapies (NRT), such as nicotine patches and gums, can help people quit smoking. But some people don’t like the patches or the gums. Research published in the June 10, 2002 issue of
Archives of Internal Medicine
suggests that new nicotine lozenges are also effective in helping smokers quit.
About the study
The study was funded by Glaxo SmithKline Consumer Healthcare, the company that manufactures the NiQuitin CQ lozenge—a nicotine lozenge. Researchers from Glaxo SmithKline and the Universities of Pittsburgh and London enrolled 1818 smokers into this study, which was conducted at research centers in the United States and the United Kingdom. Participants’ average age was 42, and on average, they had been smoking for 20 years.
All participants were age 18 or older and interested in quitting smoking. People were excluded from the study if in the last 30 days they had used nicotine or tobacco products other than cigarettes or had used any form of NRT. Other reasons for exclusion included: pregnancy, heart disease, stomach ulcer, uncontrolled hypertension, insulin-dependent diabetes, and difficulty metabolizing aspartame.
At the start of the study, smokers were divided into two groups:
High-dependency – those who smoked their first cigarette of the day within 30 minutes of waking
Low-dependency smokers – those who smoked their first cigarette of the day more than 30 minutes after waking
The 901 high-dependency smokers were randomly assigned to take either 4-mg nicotine lozenges or placebo (inactive) lozenges. The 917 low-dependency smokers were randomly assigned to receive either 2-mg nicotine lozenges or placebo lozenges.
Participants made scheduled visits to the research centers at weeks 2, 4, 6, 12, 24, and 52, though they only received lozenges through week 24. They reported whether or not they had abstained from smoking, which was confirmed by measuring carbon monoxide in their breath. At each visit, those who had smoked were eliminated from the study and only continuous abstainers remained in the study. Participants were also instructed to call an automated telephone service to report their craving levels, withdrawal symptoms, side effects, and weight gain.
Researchers compared the number of continuous abstainers in the nicotine lozenge groups with the number of continuous abstainers in the placebo groups.
After six weeks of taking the lozenge, low-dependency smokers taking the 2-mg lozenges were 2 times more likely to maintain abstinence than their counterparts taking the placebo. At six weeks, high-dependency smokers taking the 4-mg lozenge were more than 3 times more likely to maintain abstinence than their counterparts taking the placebo. At 52 weeks, those who had taken the nicotine lozenges were still 2 times more likely to have maintained abstinence than their counterparts who had taken placebo.
Heartburn, hiccups and nausea were the only side effects that occurred more often in the nicotine lozenge groups than in the placebo groups.
Although these results are interesting, there are limitations to this study. For example, we are unable to draw strong conclusions about craving levels, withdrawal symptoms, side effects, and weight gain because more than half of participants failed to use the automated telephone reporting service. In addition, this study did not directly compare the effectiveness of the lozenges with nicotine gums, patches, and inhalers.
How does this affect you?
This study suggests that nicotine lozenges are a safe and effective therapy for quitting smoking. However, more research is needed to directly compare the effectiveness of lozenges with patches, gums, and inhalers. Like the gums and inhalers, the lozenges can provide immediate “rescue” relief when cravings strike, as compared to the patch, which delivers a consistent dose throughout the day. On average, the people in this study consumed a high of 7 to 9 lozenges per day in the first few weeks, and that number dropped off over time.
The nicotine lozenges used in this study have been submitted to the U.S. Food and Drug Administration for approval to be sold in the United States.
Nicotine lozenges seem to be one more viable method of quitting smoking, a habit that significantly increases your risk of deadly diseases, such as heart disease, stroke, lung cancer, chronic bronchitis, and emphysema, to name just a few. If you’re trying to quit smoking, you may want to consider behavior therapy and support groups, as well, to help you quit.
Shiffman S, et al. Efficacy of a nicotine lozenge for smoking cessation.
Archives of Internal Medicine
. June 10, 2002;162:1267-1276.
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