Smoking, Tobacco Dependence, Tobacco Use Disorder
Conditions
Keywords
dietary supplement, nutraceutical
Brief summary
This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the effects of study product on a smoker's desire to smoke, measured by changes in scores on questionnaires given over time. Phase 2 will be a two-week extension, in which subjects will self-administer the study product and visit the study site for assessment of desire to smoke and collection of samples for the evaluation of smoking-related biomarkers.
Interventions
one dissolvable bit, one time, after a period of abstinence from smoking
one dissolvable bit, one time, after a period of abstinence from smoking
Sponsors
Study design
Eligibility
Inclusion criteria
* healthy adult smokers * using at least 1 pack of cigarettes per day, for at least 5 years
Exclusion criteria
* allergy to study product components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effect on subject's craving to smoke | 5 hours | craving is assessed by changes in questionnaire answers over time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events related to study product | 5 hours | collection of information on adverse events related to study product |
Countries
United States