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OpenTrials
Completed

NCT Number: NCT01262170

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

A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily reducing the desire to smoke

Completed

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Key information

Conditions

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

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

Subjects will orally self-administer 2 study products, each in the form of a dissolvable lozenge, and will complete questionnaires on demographics, urges to smoke, and product rating.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adult smokers
  • Smoking for at least 5 years
  • Smoking at least one (1) pack of cigarettes a day

Exclusion criteria

  • Allergy to lozenge components

Treatment and study plan

CigRx Lozenge

Dietary Supplement

lozenge made of dietary supplements

Tobacco Lozenge

Other

lozenge made of compressed cured tobacco extract

Primary outcomes

  1. Effect on subject's craving to smoke

    Time frame: 4 hours

    craving is assessed by changes in questionnaire answers over time

Secondary outcomes

  1. Collection of information on adverse events related to study products

    Time frame: 5 hours

Sponsors and collaborators

Lead sponsor

Rock Creek Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Active-Controlled, Crossover, Pilot Study to Evaluate the Safety and Efficacy of CigRx™ Lozenge, a Non-Nicotine Non-Tobacco Dietary Supplement, in Daily Smokers in Temporarily Reducing the Desire to Smoke

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 17, 2010
Registry last updated
Oct 30, 2015

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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