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:
Star Scientific, Inc
ClinicalTrials.gov Identifier:
NCT01337830
First received: April 14, 2011
Last updated: April 15, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Tobacco Use Disorder
Smoking
Other: Ariva® Silver Wintergreen
Other: Silver 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-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

Resource links provided by NLM:


Further study details as provided by Star Scientific, Inc:

Primary Outcome Measures:
  • 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.


Enrollment: 111
Study Start Date: October 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Ariva® Silver Wintergreen
Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.
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.
Other: Silver Wintergreen
Comparator product containing 6 mg silver salt and no tobacco (i.e., no nicotine), administered orally as a single dose.

Detailed Description:

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.

  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: NCT01337830

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: NCT01337830     History of Changes
Other Study ID Numbers: SSI-044
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 April 15, 2014