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A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy 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.
 
ClinicalTrials.gov Identifier: NCT01337817
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Star Scientific, Inc

Tracking Information
First Submitted Date  ICMJE April 14, 2011
First Posted Date  ICMJE April 19, 2011
Last Update Posted Date October 24, 2014
Study Start Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers [ Time Frame: 90 minutes ]
Effectiveness to be measured by the change in score on a craving questionnaire, from before to after product use.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers
Official Title  ICMJE A Randomized, Double-Blinded, Active-Controlled, Crossover, Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, Containing Tobacco and Silver Salt - in Healthy Smokers
Brief Summary Study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked.
Detailed Description

Each subject will be given an Ariva® Silver Wintergreen lozenge or an Ariva® Wintergreen lozenge on a random basis.

Once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes, and will answer questions about the experience and their craving for a cigarette.

After a washout period, each subject will repeat the steps with the second type of lozenge.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE
  • Tobacco Use Disorder
  • Smoking
Intervention  ICMJE
  • Other: Ariva Silver Wintergreen
    Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.
  • Other: Ariva Wintergreen
    Comparator product, a compressed dissolvable smokeless tobacco lozenge containing 2 mg nicotine administered orally as a single dose.
Study Arms  ICMJE
  • Experimental: Ariva Silver Wintergreen
    Subjects allow study product lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke.
    Intervention: Other: Ariva Silver Wintergreen
  • Active Comparator: Ariva Wintergreen
    Subjects allow study comparator lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke.
    Intervention: Other: Ariva Wintergreen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2011)
37
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy adult smoker
  • smoking for at least 5 years
  • smoking at least one (1) pack of cigarettes a day
  • interest in quitting smoking

Exclusion Criteria:

  • known allergy to silver or silver salts
  • pregnant or breast-feeding
  • current drug or alcohol abuse, and/or history of drug or alcohol dependence within 3 months of study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 23 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01337817
Other Study ID Numbers  ICMJE SSI-043
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Star Scientific, Inc
Study Sponsor  ICMJE Star Scientific, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria Varga, MD Star Scientific, Inc
PRS Account Star Scientific, Inc
Verification Date October 2014

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