Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Prolonged Smokeless Tobacco Abstinence at 3 Months
Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.
Jon O. Ebbert, M.D.
United States: Institutional Review Board
|Mayo Clinic||Rochester, Minnesota 55905|
|Oregon Research Institute||Eugene, Oregon 97403|