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

Rock Creek Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Tobacco Use Disorder; Smoking

Treatments: Other: Tobacco Lozenge; Dietary Supplement: CigRx Lozenge

Study type: Interventional

Funder types: Industry

Identifiers

NCT01262170

RCP-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 23 to 72 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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109 participants in 2 patient groups

CigRx Lozenge

Experimental group

Description:

CigRx Lozenge

Treatment:

Dietary Supplement: CigRx Lozenge

Tobacco Lozenge

Active Comparator group

Description:

Tobacco Lozenge

Treatment:

Other: Tobacco Lozenge