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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: October 23, 2014
Last verified: October 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 23, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 20, 2014