Phase 3
Completed N=270
Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
Smokeless Tobacco Use
Source: ClinicalTrials.gov NCT00392379 ↗
Enrolled (actual)
270
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: Prolonged Smokeless Tobacco Abstinence at 3 Months — 65; 41 Participants — p=<0.05
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prolonged Smokeless Tobacco Abstinence at 3 Months |
65; 41 | <0.05 sig |
| SECONDARY Self-reported Point Prevalence All Tobacco Abstinence at 3 Months |
60; 39 | — |
| SECONDARY Prolonged Smokeless Tobacco Abstinence at 6 Months |
41; 31 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00392379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.