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
  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
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 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: Star Scientific, Inc
ClinicalTrials.gov Identifier: NCT01337830     History of Changes
Other Study ID Numbers: SSI-044
Study First Received: April 14, 2011
Last Updated: October 23, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 29, 2014