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

R

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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