Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke
Phase 1
Completed
- Conditions
- Tobacco Use DisorderTobacco DependenceSmoking
- Interventions
- Dietary Supplement: Anatabloc(TM)Dietary Supplement: CigRx(R)
- Registration Number
- NCT01428310
- Lead Sponsor
- Rock Creek Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Anatabloc(TM) Anatabloc(TM) dissolvable bit containing dietary ingredients, binders, fillers, and flavors CigRx(R) CigRx(R) dissolvable bit containing dietary ingredients, binders, fillers, and flavors
- Primary Outcome Measures
Name Time Method effect on subject's craving to smoke 5 hours craving is assessed by changes in questionnaire answers over time
- Secondary Outcome Measures
Name Time Method adverse events related to study product 5 hours collection of information on adverse events related to study product
Trial Locations
- Locations (1)
Comfort Inn
🇺🇸Martinsburg, West Virginia, United States