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

NCT01337830 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2014-10-24

No results posted yet for this study

Summary

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

Conditions

  • Tobacco Use Disorder
  • Smoking

Interventions

OTHER

Ariva® Silver Wintergreen

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

OTHER

Silver Wintergreen

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

Sponsors & Collaborators

  • Star Scientific, Inc

    lead INDUSTRY

Principal Investigators

  • Maria Varga, MD · Star Scientific, Inc

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
23 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01337830 on ClinicalTrials.gov