A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers

Smoking Clinical Trial

Official title:

A Randomized, Double-Blinded, Active-Controlled, Crossover, Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, Containing Tobacco and Silver Salt - in Healthy Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337817
• Other study ID #: SSI-043
• Status: Completed
• Phase: Phase 1
• First received: April 14, 2011
• Last updated: October 23, 2014
• Start date: September 2009
• Est. completion date: September 2009

Study information

• Verified date: October 2014
• Source: Star Scientific, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Each subject will be given an Ariva® Silver Wintergreen lozenge or an Ariva® 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Years to 72 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Smoking
• Tobacco Use Disorder

Intervention

Other:
• Ariva Silver Wintergreen
Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.
• Ariva Wintergreen
Comparator product, a compressed dissolvable smokeless tobacco lozenge containing 2 mg nicotine administered orally as a single dose.

Locations

Country	Name	City	State
United States	Comfort Inn	Martinsburg	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Star Scientific, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers	Effectiveness to be measured by the change in score on a craving questionnaire, from before to after product use.	90 minutes	No