Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen in Reducing Cigarette Craving in Smokers
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
1 other identifier
interventional
111
1 country
1
Brief Summary
Study to determine the safety and effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 14, 2011
CompletedFirst Posted
Study publicly available on registry
April 19, 2011
CompletedOctober 24, 2014
October 1, 2014
Same day
April 14, 2011
October 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers
Effectiveness to be measured by the change in score on a craving questionnaire, from before to after product use.
90 minutes
Study Arms (2)
Ariva® Silver Wintergreen
EXPERIMENTALSubjects 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.
Silver Wintergreen
ACTIVE COMPARATORSubjects 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.
Interventions
Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.
Comparator product containing 6 mg silver salt and no tobacco (i.e., no nicotine), administered orally as a single dose.
Eligibility Criteria
You may qualify if:
- healthy adult smoker
- smoking for at least 5 years
- smoking at least one (1) pack of cigarettes a day
- interest in quitting smoking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Comfort Inn
Martinsburg, West Virginia, 25401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Varga, MD
Star Scientific, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2011
First Posted
April 19, 2011
Study Start
October 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
October 24, 2014
Record last verified: 2014-10