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

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ClinicalTrials.gov Identifier: NCT01262170
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Smoking Tobacco Use Disorder Dietary Supplement: CigRx Lozenge Other: Tobacco Lozenge Phase 1

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  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2010
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CigRx Lozenge
CigRx Lozenge
Dietary Supplement: CigRx Lozenge
lozenge made of dietary supplements
Active Comparator: Tobacco Lozenge
Tobacco Lozenge
Other: Tobacco Lozenge
lozenge made of compressed cured tobacco extract



Primary Outcome Measures :
  1. Effect on subject's craving to smoke [ Time Frame: 4 hours ]
    craving is assessed by changes in questionnaire answers over time


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


Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01262170


Locations
United States, West Virginia
Comfort Inn
Martinsburg, West Virginia, United States, 25401
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: NCT01262170     History of Changes
Other Study ID Numbers: RCP-002
First Posted: December 17, 2010    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