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

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ClinicalTrials.gov Identifier: NCT01428310
Recruitment Status : Completed
First Posted : September 2, 2011
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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
Study Start Date : September 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. effect on subject's craving to smoke [ Time Frame: 5 hours ]
    craving is assessed by changes in questionnaire answers over time


Secondary Outcome Measures :
  1. adverse events related to study product [ Time Frame: 5 hours ]
    collection of information on adverse events related to study product



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01428310     History of Changes
Other Study ID Numbers: RCP-006
First Posted: September 2, 2011    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015

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

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