Approximately 8.2 million (3.3%) of Americans ≥ 12 years of age are current smokeless tobacco (ST) users, and the prevalence of ST use has increased over the past three years. ST is increasingly being promoted as a harm reduction strategy for cigarette smoking, and two of the world's largest cigarette manufacturers have entered the ST market. ST use is estimated to be the greatest exogenous source of human exposure to cancer-causing nitrosamines. ST has been associated with oral and extra-oral cancer as well as cardiovascular and cerebrovascular mortality.
A need for efficacious interventions exists as 64% of ST users report the desire to quit. However, no pharmacotherapy has proven efficacy for increasing long-term (> 6 months) tobacco abstinence rates among ST users compared to placebo. New pharmacotherapies, drug combinations, and improved dosing of existing pharmacotherapies are needed. Previous research with nicotine patches for ST users using standard doses (up to 21 mg/day) have not increased long-term abstinence rates. However, studies of higher dose nicotine patch therapy (up to 63 mg/day) in ST users have demonstrated a dose-dependent reduction in tobacco withdrawal symptoms as well as preliminary evidence of increased long-term (> 6 months) abstinence rates compared to lower doses. The purpose of this study is to evaluate the efficacy of high dose nicotine patch therapy (42 mg/day) for increasing the 7-day point prevalence and prolonged all tobacco and ST abstinence rates at end-of-treatment (week 8), 12 and 24 weeks compared to placebo in ST users who use ≥ 3 cans/pouches per week when all subjects receive behavioral treatment for tobacco dependence. To accomplish our aims, we will randomize 60 ST users in a clinical pilot study. The work will be conducted at the Mayo Clinic in Rochester, MN.
1. are at least 18 years of age and at most 40 years of age;
2. report daily ST use for the past 12 months;
3. identify ST as their primary tobacco product;
4. use an average of ≥ 3 cans/pouches per week;
5. are in general good health (determined by medical history and screening physical examination);
6. have been provided with, understand, and have signed the informed consent.
1. are currently using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;
2. are currently pregnant or lactating;
3. have had unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months;
4. have a history of arrhythmia or an abnormal tracing on the baseline EKG;
5. have a blood pressure of greater than 140/90 or a pulse of more than 110 beats per minute;
6. have a history of severe skin allergies or dermatoses;
7. have a history of intolerance to nicotine patches;
8. have another member of their household already participating in this study;
9. are taking a medication known to interact with nicotine (i.e., clozapine);
10. are taking any prescription medication for depression or asthma
This study includes a screening period in which you will be informed of the study; if you decide to participate you will be asked to sign this study informed consent form.
Afterwards you will be asked to undergo a series of screening tests to see if you are eligible to participate in this study. The tests will include questions concerning your medical and tobacco use history, a brief physical exam, diagnostic tests to determine your nicotine dependence. If you are a woman, you will also have a pregnancy test using a urine sample.
After that you will be randomized (as in the flip of a coin) to one of two groups: 2 ? 21 mg of nicotine patches or matching placebo patches (inactive drug). You will stay on your assigned dose for 8 weeks with biweekly clinic visits (weeks 2, 4, 6,and 8).
When you complete your 8 weeks of study drug; you will return after four weeks (week 12) and then be asked to return for a final study visit (week 24).
Everyone in study will also receive nicotine dependence counseling.
Last updated: 04/12/2013
NCT ID: NCT00939029