Phase 4
Completed N=250
Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers
Cigarette Smoking
Source: ClinicalTrials.gov NCT00843622 ↗
Enrolled (actual)
250
Serious AEs
1.6%
Results posted
Jun 2014
Primary outcomePrimary: Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm — 5; 2 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm |
5; 2 | — |
| SECONDARY Minnesota Nicotine Withdrawal Scale |
— | — |
| SECONDARY Fagerström Test for Nicotine Dependence |
— | — |
| SECONDARY Biomarkers |
— | — |
| SECONDARY Point Prevalence Smoking Cessation |
— | — |
| SECONDARY Continuous Smoking Cessation |
— | — |
Eligibility Criteria
Inclusion Criteria
- Cigarette smoker who smoke more than 9 cigarettes per day (average during past month)
- Daily smoking more than 1 year
- Motivated to quit smoking using a smokefree tobacco product
- Good general health
Exclusion Criteria
- Use of smokefree/smokeless tobacco during past 6 months or any type of pharmaceutical product for smoking cessation during past 3 months
- Unable to refrain from nicotine replacement therapy during the study
- Current oral condition that could be made worse by study interventions
- History of clinically significant renal, hepatic, neurological, or chronic pulmonary disease that in the judgement of the investigator might preclude participation
- History of significant cardiovascular disease, including myocardial infarction, within the last 3 months, significant cardiac arrythmias, or poorly controlled hypertension that in the judgement of the investigator might preclude participation
- History of alcohol or substance abuse other than cigarette smoking within the past year
Data sourced from ClinicalTrials.gov (NCT00843622). 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.