Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment
- are at least 18 years of age;
- report smokeless tobacco (ST) as their primary tobacco of use;
- have used ST daily for the past 6 months;
- are in general good health (determined by medical history and screening physical examination);
- have been provided with, understand, and have signed the informed consent.
During the clinic screen visit (visit 1) you will be informed about details of the study, after reading this document which informs you of your rights concerning study participation, you will be given the opportunity to sign it and thereby indicating your willingness to participate in this study. After you sign this consent form, a series of screening tests will be conducted to see if you are eligible to participate in the study. If you are found to be eligible for study participation you will return for a baseline visit (visit 2), whereby a physical exam and medical history will be done by a study physician. After that you will be randomized (as in the flip of a coin) to one of two groups: 4 mg Nicotine Lozenges ad lib per day or a matching placebo. You will stay on your assigned dose for 12 weeks with weekly or biweekly clinic visits (visit 3-6). When they complete you 12 weeks of study drug, you will be asked to return for a final study visit (visit 7).
During each study visit, vital signs will be measured and you will be asked questions about nicotine withdrawal and the drug side effects and concomitant medications taken. At each visit tobacco use status will be documented and tobacco abstinence confirmed by expired air Carbon Monoxide and urine cotinine measures. Please remember that your target quit day will be the day after your randomization day, the day you actually begin taking the study medication.
Participants will be in this study for a total of six months and will take nicotine lozenges for 12 weeks.
Last updated: 04/16/2013
NCT ID: NCT00392379