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Completed

NCT Number: NCT01336816

A Pilot Study to Evaluate the Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge

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.

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Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders

Age range

23 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Comfort Inn

Martinsburg, West Virginia, 25401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ariva Silver Wintergreen

Other

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

Placebo Wintergreen

Other

Placebo Wintergreen lozenge containing no tobacco, nicotine, or silver salt, administered orally as a single dose.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Star Scientific, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 18, 2011
Registry last updated
Oct 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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