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

Smoking Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262170
• Other study ID #: RCP-002
• Status: Completed
• Phase: Phase 1
• First received: December 15, 2010
• Last updated: October 29, 2015
• Start date: April 2010
• Est. completion date: April 2010

Study information

• Verified date: October 2015
• Source: Rock Creek Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Years to 72 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking
• Tobacco Use Disorder

Intervention

Dietary Supplement:
• CigRx Lozenge
lozenge made of dietary supplements

Other:
• Tobacco Lozenge
lozenge made of compressed cured tobacco extract

Locations

Country	Name	City	State
United States	Comfort Inn	Martinsburg	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Rock Creek Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on subject's craving to smoke	craving is assessed by changes in questionnaire answers over time	4 hours	No
Secondary	Collection of information on adverse events related to study products		5 hours	No