Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Mayo Clinic

Status and phase

Completed

Phase 3

Conditions

Smokeless Tobacco Use

Treatments

Drug: Nicotine Lozenges

Drug: Placebo lozenge

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00392379

R01CA121165 (U.S. NIH Grant/Contract)

06-003091

Details and patient eligibility

About

This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.

Full description

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

Enrollment

270 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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.