- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01336816
A Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge
October 23, 2014 updated by: Star Scientific, Inc
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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West Virginia
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Martinsburg, West Virginia, United States, 25401
- Comfort Inn
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 72 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Placebo Wintergreen lozenge containing no tobacco, nicotine, or silver salt, administered orally as a single dose.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers
Time Frame: 90 minutes
|
Effectiveness measured by change in scores over time across several questionnaires.
|
90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
April 14, 2011
First Submitted That Met QC Criteria
April 15, 2011
First Posted (Estimate)
April 18, 2011
Study Record Updates
Last Update Posted (Estimate)
October 24, 2014
Last Update Submitted That Met QC Criteria
October 23, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSI-042
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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