Overview

Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Swedish Match AB
Treatments:
Lobeline
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