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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
History of Changes
  Purpose

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
Smoking
 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:

U.S. FDA Resources

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336816

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

No publications provided

Responsible Party: Maria Varga, MD, Star Scientific, Inc.
ClinicalTrials.gov Identifier: NCT01336816     History of Changes
Other Study ID Numbers: SSI-042
Study First Received: April 14, 2011
Last Updated: April 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Star Scientific, Inc:
smoking
smokeless
aversion
nicotine
nicotine replacement

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013