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Clinical Trials/NCT01428310
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

Rock Creek Pharmaceuticals, Inc.1 site in 1 country109 target enrollmentSeptember 2011

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
December 2011
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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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