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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: October 29, 2015
Last verified: October 2015
  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
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Effect on subject's craving to smoke [ Time Frame: 4 hours ]
    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 ]

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   (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
  Contacts and Locations
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, see Learn About Clinical Studies.

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

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: October 29, 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

ClinicalTrials.gov processed this record on August 17, 2017