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

Rock Creek Pharmaceuticals, Inc.109 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

109

Conditions

Smoking Tobacco Use Disorder

Interventions

CigRx LozengeDIETARY_SUPPLEMENT

lozenge made of dietary supplements

Tobacco LozengeOTHER

lozenge made of compressed cured tobacco extract

Eligibility

Sex: ALLMin age: 23 YearsMax age: 72 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Comfort Inn

Martinsburg, West Virginia, United States

Outcomes

Primary Outcomes

Effect on subject's craving to smoke

craving is assessed by changes in questionnaire answers over time

Time frame: 4 hours

Secondary Outcomes

Collection of information on adverse events related to study products

Time frame: 5 hours

Data from ClinicalTrials.gov

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