NCT01428310
Completed
Phase 1
A Single Center, Single-Blind, Randomized, Crossover Pilot Study to Evaluate the Safety and Effects of Anatabloc™, a Dietary Supplement, in Reducing the Urge to Smoke in Daily Smokers Followed by an Open-Label Extension
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Tobacco Use Disorder
- Sponsor
- Rock Creek Pharmaceuticals, Inc.
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- effect on subject's craving to smoke
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
effect on subject's craving to smoke
Time Frame: 5 hours
craving is assessed by changes in questionnaire answers over time
Secondary Outcomes
- adverse events related to study product(5 hours)
Study Sites (1)
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