CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 250 enrolled
Drug / intervention
Low-nitrosamine smokefree tobacco product for oral use +1 moredrug
Likely dose
Low-nitrosamine smokefree tobacco product for oral use 0.5 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00843622
NCT00843622Phase 4Completed
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A Controlled Study of the Ability of a Traditional Swedish Smokeless Tobacco Product ("Snus") to Increase the Quit Rate Among Cigarette Smokers Who Wish to Stop Smoking

Swedish Match AB·interventional·Posted Feb 13, 2009·Updated Jun 17, 2014

In Brief

A Phase 4 clinical trial evaluating Low-nitrosamine smokefree tobacco product for oral use and Non-tobacco, non-nicotine placebo product for Cigarette Smoking. Completed, enrolled 250 participants across 4 sites.

Detailed Summary

The study aims to assess if use of a low-nitrosamine, Swedish, smokefree tobacco product for oral use ("snus") can increase the quit rate among cigarette smokers who wish to stop smoking

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCigarette Smoking
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 13, 2009
Enrollment StartFeb 1, 2009
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.4 years ago

Interventions

Low-nitrosamine smokefree tobacco product for oral usedrug

Smokeless tobacco in paper sachets containing 1.0 or 0.5 g of the product. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke \>15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.

Non-tobacco, non-nicotine placebo productother

Placebo product in paper sachets containing 1.0 or 0.5 g. Product made of cocoa bean fibers and oat fibers. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke \>15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.