Phase 2
Completed N=332
Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use
Source: ClinicalTrials.gov NCT00218296 ↗Enrolled (actual)
332
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence) — 31; 17 percentage of randomized — p=0.04
Summary
Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence) |
31; 17 | 0.04 sig |
| PRIMARY Percent Prolonged Abstinence From Tobacco at Week 12 |
13; 4 | 0.019 sig |
| PRIMARY Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence) |
20; 10 | 0.03 sig |
| PRIMARY Percent Prolonged Abstinence From Tobacco at Week 26 |
11; 1 | .002 sig |
| PRIMARY Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence) |
20; 11 | 0.056 |
| PRIMARY Percent Prolonged Abstinence From Tobacco at Week 32 |
11; 1 | 0.002 sig |
Eligibility Criteria
Inclusion Criteria
- No interest in stopping ST use within 90 days of study entry
- Daily use of ST in the 6 months prior to study entry
Exclusion Criteria
- Current use of tobacco or nicotine products, other than ST
- Current unstable medical and mental health conditions
- Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00218296). 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.