Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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

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.

Condition Intervention Phase
Tobacco Use Disorder
Other: Ariva Silver Wintergreen
Other: Placebo Wintergreen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Star Scientific, Inc:

Primary Outcome Measures:
  • 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.

Enrollment: 43
Study Start Date: July 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Ariva Silver Wintergreen
Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.
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.
Other: Placebo Wintergreen
Placebo Wintergreen lozenge containing no tobacco, nicotine, or silver salt, administered orally as a single dose.

Detailed Description:

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.


Ages Eligible for Study:   23 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  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 identifier: NCT01336816

United States, West Virginia
Comfort Inn
Martinsburg, West Virginia, United States, 25401
Sponsors and Collaborators
Star Scientific, Inc
Principal Investigator: Maria Varga, MD Star Scientific, Inc
  More Information

No publications provided

Responsible Party: Star Scientific, Inc Identifier: NCT01336816     History of Changes
Other Study ID Numbers: SSI-042
Study First Received: April 14, 2011
Last Updated: October 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Star Scientific, Inc:
nicotine replacement

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders processed this record on February 27, 2015