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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tobacco Use Disorder Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Ariva Silver Wintergreen

Intervention Type OTHER

Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.

Ariva Wintergreen

Subjects allow study comparator lozenge to dissolve in mouth, smoke a cigarette, then answer questionnaires about product taste and effect on desire to smoke.

Group Type ACTIVE_COMPARATOR

Ariva Wintergreen

Intervention Type OTHER

Comparator product, a compressed dissolvable smokeless tobacco lozenge containing 2 mg nicotine administered orally as a single dose.

Interventions

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Ariva Silver Wintergreen

Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.

Intervention Type OTHER

Ariva Wintergreen

Comparator product, a compressed dissolvable smokeless tobacco lozenge containing 2 mg nicotine administered orally as a single dose.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

23 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes