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

Phase 1

Completed

• Conditions: Smoking; Tobacco Use Disorder
• Interventions: Dietary Supplement: CigRx Lozenge; Other: Tobacco Lozenge

• Registration Number: NCT01262170
• Lead Sponsor: Rock Creek Pharmaceuticals, Inc.

Brief 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.

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CigRx Lozenge	CigRx Lozenge	CigRx Lozenge
Tobacco Lozenge	Tobacco Lozenge	Tobacco Lozenge

Primary Outcome Measures

Name	Time	Method
Effect on subject's craving to smoke	4 hours	craving is assessed by changes in questionnaire answers over time

Secondary Outcome Measures

Name	Time	Method
Collection of information on adverse events related to study products	5 hours

Trial Locations

Locations (1)

Comfort Inn; 🇺🇸 Martinsburg, West Virginia, United States