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 Non-Nicotine Non-Tobacco Dietary Supplement, in Daily Smokers in Temporarily Reducing the Desire to Smoke

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Rock Creek Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 23 Years – 72 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Smoking
• Tobacco Use Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CigRx Lozenge	lozenge made of dietary supplements
OTHER	Tobacco Lozenge	lozenge made of compressed cured tobacco extract

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2010-12-17
• Last updated: 2015-10-30

Locations

1 site across 1 country: United States