Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen in Reducing Cigarette Craving in Smokers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Star Scientific, Inc
ClinicalTrials.gov Identifier:
NCT01337830
First received: April 14, 2011
Last updated: October 23, 2014
Last verified: October 2014

April 14, 2011
October 23, 2014
October 2010
October 2010   (final data collection date for primary outcome measure)
Effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
Effectiveness to be measured by the change in score on a craving questionnaire, from before to after product use.
Same as current
Complete list of historical versions of study NCT01337830 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen in Reducing Cigarette Craving in Smokers
A Randomized, Double-Blind, Crossover, Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, in Reducing Craving for a Cigarette in Daily Smokers

Study to determine the safety and effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers.

Each subject will be given an Ariva® Silver Wintergreen lozenge or a Silver Wintergreen lozenge, which contains only silver salt, 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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Tobacco Use Disorder
  • Smoking
  • 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: Silver Wintergreen
    Comparator product containing 6 mg silver salt and no tobacco (i.e., no nicotine), administered orally as a single dose.
  • Experimental: Ariva® Silver Wintergreen
    Subjects allow study product lozenge to dissolve in the mouth, smoke a cigarette, then answer questionnaires about the effect of the product on both their desire to smoke and on cigarette taste.
    Intervention: Other: Ariva® Silver Wintergreen
  • Active Comparator: Silver Wintergreen
    Subjects allow comparator product lozenge to dissolve in the mouth, smoke a cigarette, then answer questionnaires about the effect of the product on both their desire to smoke and on cigarette taste.
    Intervention: Other: Silver Wintergreen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
23 Years to 72 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01337830
SSI-044
No
Star Scientific, Inc
Star Scientific, Inc
Not Provided
Principal Investigator: Maria Varga, MD Star Scientific, Inc
Star Scientific, Inc
October 2014

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