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Clinical Trials/NCT01336816
NCT01336816CompletedPhase 1

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

Star Scientific, Inc2 sites in 1 country43 target enrollmentStarted: July 2009Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
43
Locations
2
Primary Endpoint
Effectiveness of Ariva® Silver Wintergreen lozenge on discouraging smoking in smokers

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
23 Years to 72 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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