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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01428310
First received: September 1, 2011
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Tobacco Use Disorder
Tobacco Dependence
Smoking
Dietary Supplement: Anatabloc(TM)
Dietary Supplement: CigRx(R)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Rock Creek Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • effect on subject's craving to smoke [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
    craving is assessed by changes in questionnaire answers over time


Secondary Outcome Measures:
  • adverse events related to study product [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
    collection of information on adverse events related to study product


Enrollment: 109
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anatabloc(TM)
dissolvable bit containing dietary ingredients, binders, fillers, and flavors
Dietary Supplement: Anatabloc(TM)
one dissolvable bit, one time, after a period of abstinence from smoking
Active Comparator: CigRx(R)
dissolvable bit containing dietary ingredients, binders, fillers, and flavors
Dietary Supplement: CigRx(R)
one dissolvable bit, one time, after a period of abstinence from smoking

  Eligibility

Ages Eligible for Study:   23 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428310

Locations
United States, West Virginia
Comfort Inn
Martinsburg, West Virginia, United States, 25404
Sponsors and Collaborators
Rock Creek Pharmaceuticals, Inc.
Investigators
Principal Investigator: Maria Varga, MD Star Scientific, Inc
  More Information

No publications provided

Responsible Party: Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01428310     History of Changes
Other Study ID Numbers: RCP-006
Study First Received: September 1, 2011
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rock Creek Pharmaceuticals, Inc.:
dietary supplement
nutraceutical

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 14, 2014