New smoking cessation tool being studied

DURHAM, N.C. - Smokers may eventually have another available tool – an oral nicotine solution that can be added to their favorite beverage – to help them kick the habit, according to Dr. Eric C. Westman, assistant professor in the department of medicine at Duke University Medical Center. Westman and colleagues said the nicotine solution can be added to coffee, tea, soda, beer, lemonade or other beverages and consumed orally several times a day in lieu of smoking. The solution was patented (#6,211,194) April 3 in the United States. After conducting a successful study of 25 smokers who used the solution, the researchers now are seeking a pharmaceutical company to fund larger clinical trials. "One of the advantages of the oral solution is that it involves a hand-to-mouth action, similar to that of smoking," Westman said. "Also, the nicotine is metabolized fairly rapidly, providing a quicker nicotine boost than is provided by a nicotine patch. And unlike nicotine gum, which comes in regular, mint and orange flavors, the oral solution can be flavored in almost any way the smoker chooses to flavor it." Results of the small pilot study will be published later this year.

Smokers in the study chose a "smoking quit date" and were given vials of the solution to mix into their beverages with instructions to use it as needed for smoking urges during a 12-week period. The taste of the solution is masked by the beverage that is used. Participants consumed anywhere from 2.5 milligrams to 10 milligrams of the solution per drink. Three milligrams consumed orally is close to the one milligram amount of nicotine typically acquired by smoking a cigarette. Westman said abstinence rates reported by the participants at four weeks, three months and six months were 28 percent, 24 percent and 20 percent, respectively. He said these rates are typical of most of the smoking-intervention tools currently available. Participants received only minimal behavioral counseling during the study. Side effects from using the oral solution were minimal in the 25 participants studied. The only participant to drop out of the study complained of a burning sensation at the site of dental work.

"Nicotine-replacement therapy is the most widely used pharmacologic treatment for smoking cessation," said Westman. "It is thought to work by reducing withdrawal symptoms, or by separating the rewarding aspects of nicotine from the behavior of smoking. Besides the patch and nicotine gums, the other forms of nicotine replacement available are the nasal spray, oral inhaler, a lozenge and sublingual tablets. "There are 435,000 deaths per year in the United States from cigarette smoking," he added. "Obviously, we must continue to research various methods of smoking cessation to provide as much assistance as we can to help people quit." Early research has shown that nicotine also may be useful for patients with ulcerative colitis, attention deficit disorder and Alzheimer's disease. If further research supports the benefits of nicotine in these patients, Westman said having a variety of methods for administering nicotine will be helpful.

The other patent awardees were Jed Rose and Keith Tomlin of Duke.

Note to editors: Dr. Eric Westman can be reached at 919-416-5242 or ewestman@acpub.duke.edu