A Pilot Study to Evaluate Safety and Efficacy of CigRx™ in Smokers

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

A Randomized, Double-Blind, Active-Controlled, Crossover, Pilot Study to Evaluate the Safety and Efficacy of CigRx™ Lozenge, a Non-Nicotine Non-Tobacco Dietary Supplement, in Daily Smokers in Temporarily Reducing the Desire to Smoke

A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily reducing the desire to smoke

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will orally self-administer 2 study products, each in the form of a dissolvable lozenge, and will complete questionnaires on demographics, urges to smoke, and product rating.

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, 25401
        • 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
  • Smoking for at least 5 years
  • Smoking at least one (1) pack of cigarettes a day

Exclusion Criteria:

  • Allergy to lozenge 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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CigRx Lozenge
Dietary supplement: CigRx Lozenge
lozenge made of dietary supplements
ACTIVE_COMPARATOR: Tobacco Lozenge
Other: Tobacco Lozenge
lozenge made of compressed cured tobacco extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on subject's craving to smoke
Time Frame: 4 hours
craving is assessed by changes in questionnaire answers over time
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Collection of information on adverse events related to study products
Time Frame: 5 hours
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

April 1, 2010

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

December 15, 2010

First Submitted That Met QC Criteria

December 16, 2010

First Posted (ESTIMATE)

December 17, 2010

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-002

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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