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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01262170

Enrollment

109

Registered

2010-12-17

Start date

2010-04-30

Completion date

2010-04-30

Last updated

2015-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking, Tobacco Use Disorder

Keywords

dietary supplement, nutraceutical

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.

Interventions

DIETARY_SUPPLEMENTCigRx Lozenge

lozenge made of dietary supplements

OTHERTobacco Lozenge

lozenge made of compressed cured tobacco extract

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

23 Years to 72 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Collection of information on adverse events related to study products	5 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026