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

NCT01428310 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2015-10-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Rock Creek Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Maria Varga, MD · Star Scientific, Inc

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
23 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-10-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01428310 on ClinicalTrials.gov