A Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge

This study has been completed.
Sponsor:
Information provided by:
Star Scientific, Inc
ClinicalTrials.gov Identifier:
NCT01336816
First received: April 14, 2011
Last updated: April 15, 2011
Last verified: April 2011

April 14, 2011
April 15, 2011
July 2009
July 2009   (final data collection date for primary outcome measure)
Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
Effectiveness measured by change in scores over time across several questionnaires.
Same as current
Complete list of historical versions of study NCT01336816 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge
A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, Containing Tobacco and Silver Salt - in Healthy Smokers

This is a 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.

Each subject will be given an Ariva® Silver Wintergreen lozenge or a Placebo 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.

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: Placebo Wintergreen
    Placebo Wintergreen lozenge containing no tobacco, nicotine, or silver salt, administered orally as a single dose.
  • 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
  • Placebo Comparator: Placebo Wintergreen
    Subjects allow study placebo lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke.
    Intervention: Other: Placebo Wintergreen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
July 2009
July 2009   (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
 
NCT01336816
SSI-042
No
Maria Varga, MD, Star Scientific, Inc.
Star Scientific, Inc
Not Provided
Principal Investigator: Maria Varga, MD Star Scientific, Inc
Star Scientific, Inc
April 2011

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