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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01337817

Tobacco Use Disorder Smoking

COMPLETED PHASE1

A Pilot Study to Evaluate Safety and Efficacy of CigRx™ in Smokers

NCT01262170

Smoking Tobacco Use Disorder

COMPLETED PHASE1

Long-term Varenicline Treatment for Smoking Cessation

NCT00828113

Smoking

COMPLETED PHASE4

Varenicline In-Patient Study

NCT01413516

Smoking Cessation

COMPLETED PHASE2

Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking

NCT00282984

Smoking Cessation

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Disorder Smoking

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ariva® Silver Wintergreen

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.

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.

Silver Wintergreen

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.

Group Type ACTIVE_COMPARATOR

Silver Wintergreen

Intervention Type OTHER

Comparator product containing 6 mg silver salt and no tobacco (i.e., no nicotine), administered orally as a single dose.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Silver Wintergreen

Comparator product containing 6 mg silver salt and no tobacco (i.e., no nicotine), administered orally as a single dose.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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