Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke

Rock Creek Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Tobacco Dependence; Tobacco Use Disorder; Smoking

Treatments: Dietary Supplement: Anatabloc(TM); Dietary Supplement: CigRx(R)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01428310

RCP-006

Details and patient eligibility

About

This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the effects of study product on a smoker's desire to smoke, measured by changes in scores on questionnaires given over time. Phase 2 will be a two-week extension, in which subjects will self-administer the study product and visit the study site for assessment of desire to smoke and collection of samples for the evaluation of smoking-related biomarkers.

Enrollment: 109 patients

Sex: All

Ages: 23 to 72 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy adult smokers
• using at least 1 pack of cigarettes per day, for at least 5 years

Exclusion criteria

• allergy to study product components

Trial design

109 participants in 2 patient groups

Anatabloc(TM)

Active Comparator group

Description:

dissolvable bit containing dietary ingredients, binders, fillers, and flavors

Treatment:

Dietary Supplement: Anatabloc(TM)

CigRx(R)

Active Comparator group

Description:

dissolvable bit containing dietary ingredients, binders, fillers, and flavors

Treatment:

Dietary Supplement: CigRx(R)