NCT01428310

Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Rock Creek Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 23 Years – 72 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Use Disorder
• Tobacco Dependence
• Smoking

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Anatabloc(TM)	one dissolvable bit, one time, after a period of abstinence from smoking
DIETARY_SUPPLEMENT	CigRx(R)	one dissolvable bit, one time, after a period of abstinence from smoking

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2011-09-02
• Last updated: 2015-10-30

Locations

1 site across 1 country: United States