Phase 4 N=432 Randomized Double-blind Treatment

Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

Tobacco Use Cessation

Bottom Line

View on ClinicalTrials.gov: NCT00717093 ↗

Enrolled (actual)

432

Serious AEs

1.2%

Results posted

May 2010

Primary outcome: Primary: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco — 125; 85 participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Varenicline Tartrate (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Apr 2009

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

Summary

The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.

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.

View full record on ClinicalTrials.gov →

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.