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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: August 17, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Smoking
Tobacco Use Disorder
 Dietary Supplement: CigRx Lozenge
Other: Tobacco Lozenge
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rock Creek Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Collection of information on adverse events related to study products [ Time Frame: 5 hours ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: April 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   23 Years to 72 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01262170     History of Changes
Other Study ID Numbers: RCP-002
Study First Received: December 15, 2010
Last Updated: August 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rock Creek Pharmaceuticals, Inc.:
dietary supplement
nutraceutical

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013