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

Star Scientific, Inc

Status and phase: Completed; Phase 1

Conditions: Tobacco Use Disorder; Smoking

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01337830

SSI-044

Details and patient eligibility

About

Study to determine the safety and effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers.

Full 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.

Enrollment: 111 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

111 participants in 2 patient groups

Ariva® Silver Wintergreen

Experimental group

Description:

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

Treatment:

Other: Ariva® Silver Wintergreen

Silver Wintergreen

Active Comparator group

Description:

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

Treatment:

Other: Silver Wintergreen