Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen in Reducing Cigarette Craving in Smokers

Smoking Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337830
• Other study ID #: SSI-044
• Status: Completed
• Phase: Phase 1
• First received: April 14, 2011
• Last updated: October 23, 2014
• Start date: October 2010
• Est. completion date: October 2010

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 Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• 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.
• Silver Wintergreen
Comparator product containing 6 mg silver salt and no tobacco (i.e., no 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 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	No