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

NCT ID: NCT01428310

Last Updated: 2015-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco Use Disorder Tobacco Dependence Smoking

Keywords

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dietary supplement nutraceutical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Anatabloc(TM)

dissolvable bit containing dietary ingredients, binders, fillers, and flavors

Group Type ACTIVE_COMPARATOR

Anatabloc(TM)

Intervention Type DIETARY_SUPPLEMENT

one dissolvable bit, one time, after a period of abstinence from smoking

CigRx(R)

dissolvable bit containing dietary ingredients, binders, fillers, and flavors

Group Type ACTIVE_COMPARATOR

CigRx(R)

Intervention Type DIETARY_SUPPLEMENT

one dissolvable bit, one time, after a period of abstinence from smoking

Interventions

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Anatabloc(TM)

one dissolvable bit, one time, after a period of abstinence from smoking

Intervention Type DIETARY_SUPPLEMENT

CigRx(R)

one dissolvable bit, one time, after a period of abstinence from smoking

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

23 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rock Creek Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Varga, MD

Role: PRINCIPAL_INVESTIGATOR

Star Scientific, Inc

Locations

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Comfort Inn

Martinsburg, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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RCP-006

Identifier Type: -

Identifier Source: org_study_id