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Completed

NCT Number: NCT01337830

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

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

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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 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.

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.

Silver Wintergreen

Other

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

Primary outcomes

  1. Effectiveness of Ariva® Silver Wintergreen lozenge on reducing craving for a cigarette in daily smokers

    Time frame: 90 minutes

    Effectiveness to be measured by the change in score on a craving questionnaire, from before to after product use.

Sponsors and collaborators

Lead sponsor

Star Scientific, Inc

Industry

Registry information

Official study title

A Randomized, Double-Blind, Crossover, Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen, a Smoking Aversive Lozenge, in Reducing Craving for a Cigarette in Daily Smokers

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 19, 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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