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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01262170
First received: December 15, 2010
Last updated: September 3, 2013
Last verified: September 2013

December 15, 2010
September 3, 2013
April 2010
April 2010   (final data collection date for primary outcome measure)
Effect on subject's craving to smoke [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
craving is assessed by changes in questionnaire answers over time
Same as current
Complete list of historical versions of study NCT01262170 on ClinicalTrials.gov Archive Site
Collection of information on adverse events related to study products [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pilot Study to Evaluate Safety and Efficacy of CigRx™ in Smokers
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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Smoking
  • Tobacco Use Disorder
  • Dietary Supplement: CigRx Lozenge
    lozenge made of dietary supplements
  • Other: Tobacco Lozenge
    lozenge made of compressed cured tobacco extract
  • Experimental: CigRx Lozenge
    CigRx Lozenge
    Intervention: Dietary Supplement: CigRx Lozenge
  • Active Comparator: Tobacco Lozenge
    Tobacco Lozenge
    Intervention: Other: Tobacco Lozenge
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
23 Years to 72 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01262170
RCP-002
No
Rock Creek Pharmaceuticals, Inc.
Rock Creek Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Maria Varga, MD Star Scientific, Inc
Rock Creek Pharmaceuticals, Inc.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP