Smokeless tobacco use is a serious health threat to the approximately 6 million regular users of the drug causing various cancers and other health problems. The California Baseline Smoking Survey 199O-1991 found a region in northern California which had a smokeless tobacco use rate of 10.4% among their adult males as compared to a 3.5% rate across the whole state and 6% nationally. Very little is currently known about effective methods of cessation for smokeless tobacco. To date there have been only three published studies of adult smokeless tobacco cessation interventions. None of these published studies has examined the use of nicotine replacement therapy.

In this study we propose to conduct a randomized experiment comparing the effectiveness of self-help materials plus nicotine patch and self-help materials plus placebo patch with 400 smokeless tobacco users. In this double blind study, subjects will be screened and interviewed by phone and receive materials and patches from pharmacists trained in the study protocol. All subjects will set a quit date prior to receiving the intervention and will be provided with phone support/counseling approximately one week after their set quit date. All 400 smokeless tobacco users will be assessed at baseline,3, 6, and 12 months and saliva cotinine verification of tobacco use status will be done at 6 months.

In addition to the randomized trial, we propose to study a general population sample (N=150) of smokeless tobacco users selected through random-digit dial telephone interviewing to explore differences between smokeless tobacco users in general and users who participate in the- cessation interventions. The sample will be measured at baseline and at 3, 6, and 12 month intervals.

R01CA064285

1995-09-25

2000-12-31