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Cancer Control Research

Abstract

Although the use of cigarettes is declining among all populations, the use of spitting tobacco (ST) (particularly oral snuff) has doubled among adolescent males in the last 15 years. The South currently has the highest prevalence rates of any region in the country, but there are pockets of high usage throughout the country. The use of spitting tobacco has been causally linked to oral cancer, the incidence of which is higher in the U.S. than cervical cancer. Besides the life-threatening link with cancer, ST use has also been shown to cause significant dental problems including tooth loss and periodontal disease. To date, nicotine replacement therapy has not been tested on adolescent ST users, although it has been shown to be effective for adult smokers. This study is a pilot study of a Phase III (Controlled Intervention Trial) study. It addresses the Healthy People 2000 goal (#3.9) of reducing spitting tobacco use "among males aged 12-24 to a prevalence of no more than 4%." The first aim of this study is to develop a behavioral intervention program based on NCI-developed educational materials, to be used in conjunction with a pharmacological adjunct, the transdermal nicotine patch . The theoretical model for this intervention will be Expectancy Theory. The second aim is to test recruitment and retention methods that can be applied in a full-scale experimental study of adolescent ST users. The third aim is to conduct a randomized, double- blind, placebo-controlled, experimental study comparing the success rates of three groups of adolescent ST users enrolled in a ST cessation program. Subjects for this pilot study will be high school senior age males, who are presently residing in the Little Rock area, who have been using ST regularly for at least l year, and who want to quit. These subjects (N=60) will be randomly divided into 3 groups; the first group will receive only the "usual care" that would be offered to any ST user in a physician's office: 3-5 minute counseling, distribution of self-help materials, and a phone call two weeks later. The second group will receive the NCI-based behavioral intervention that will involve six one-hour weekly sessions and application of placebo transdermal patches, followed by one year of regular, frequent telephone counseling. The third group will receive the same intervention as Group Two but will receive active nicotine transdermal patches. Changes in spitting tobacco use will be measured immediately after the interventions, and every 3 months thereafter for l year. Validation of abstinence immediately post-intervention and at l year will be by urinary cotinine testing. A health educator will provide the educational interventions, administer the in-person surveys, and conduct the telephone surveys every 3 months. The telephone surveys will include counseling to help abstainers "stay quit" and to encourage recidivists to try again. Incentives will be provided at every observation point and during the intervention. A special newsletter on "staying quit" will be sent to all members of the two experimental groups on a quarterly basis. The findings from this pilot study will determine which recruitment and retention methods work best in longitudinal studies of adolescents, what success rates may generally be expected in each of the groups, and thus will inform a larger study on the necessary sample size to reduce attrition bias and to maintain adequate statistical power. A larger study would then be able to better address the question of whether nicotine transdermal batches serve as useful adjuncts to behavioral interventions in adolescent populations.