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

Star Scientific, Inc

Status and phase: Completed; Phase 1

Conditions: Tobacco Use Disorder; Smoking

Treatments: Other: Ariva Wintergreen; Other: Ariva Silver Wintergreen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01337817

SSI-043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 23 to 72 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

37 participants in 2 patient groups

Ariva Silver Wintergreen

Experimental group

Description:

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

Treatment:

Other: Ariva Silver Wintergreen

Ariva Wintergreen

Active Comparator group

Description:

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

Treatment:

Other: Ariva Wintergreen