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

October 29, 2015 updated by: Rock Creek Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Martinsburg, West Virginia, United States, 25404
        • Comfort Inn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect on subject's craving to smoke
Time Frame: 5 hours
craving is assessed by changes in questionnaire answers over time
5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events related to study product
Time Frame: 5 hours
collection of information on adverse events related to study product
5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rock Creek Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 1, 2011

First Submitted That Met QC Criteria

September 1, 2011

First Posted (Estimate)

September 2, 2011

Study Record Updates

Last Update Posted (Estimate)

October 30, 2015

Last Update Submitted That Met QC Criteria

October 29, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCP-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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