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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01262170
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : October 30, 2015
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.

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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
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT01262170

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United States, West Virginia
Comfort Inn
Martinsburg, West Virginia, United States, 25401
Sponsors and Collaborators
Rock Creek Pharmaceuticals, Inc.
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Principal Investigator: Maria Varga, MD Star Scientific, Inc
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Responsible Party: Rock Creek Pharmaceuticals, Inc. Identifier: NCT01262170    
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
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders