Phase 4
Completed N=432
Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use
Tobacco Use Cessation
Source: ClinicalTrials.gov NCT00717093 ↗
Enrolled (actual)
432
Serious AEs
1.2%
Results posted
May 2010
Primary outcomePrimary: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco — 125; 85 participants — p=<0.0001
Summary
The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco |
125; 85 | <0.0001 sig |
| SECONDARY Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use |
140; 101; 135; 96; 132; 93 | 0.0118 sig |
| SECONDARY Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco |
102; 78 | 0.0063 sig |
| SECONDARY Number of Subjects With 7-day Point Prevalence (PP) of Abstinence at the End of Treatment (Week 12) and at the End of Study (Week 26) |
123; 85; 102; 88 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female daily smokeless tobacco users aged 18 years and older, who are motivated to stop use of all tobacco products.
- Subjects must be daily users of nicotine containing smokeless tobacco and using smokeless tobacco on at least 8 occasions per day averaged over a week.
- Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence >3 months in the past year.
Exclusion Criteria
- Subjects using nicotine containing products (including smoking tobacco) other than smokeless tobacco for 3 months prior to screening.
- Subjects with exhaled Carbon Monoxide (CO) >10 ppm at baseline.
- Subjects who have used varenicline, bupropion, or NRT within 3 months of screening.
- Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness.
Data sourced from ClinicalTrials.gov (NCT00717093). 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.