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

NCT ID: NCT01262170

Last Updated: 2015-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Smoking Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CigRx Lozenge

CigRx Lozenge

Group Type EXPERIMENTAL

CigRx Lozenge

Intervention Type DIETARY_SUPPLEMENT

lozenge made of dietary supplements

Tobacco Lozenge

Tobacco Lozenge

Group Type ACTIVE_COMPARATOR

Tobacco Lozenge

Intervention Type OTHER

lozenge made of compressed cured tobacco extract

Interventions

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CigRx Lozenge

lozenge made of dietary supplements

Intervention Type DIETARY_SUPPLEMENT

Tobacco Lozenge

lozenge made of compressed cured tobacco extract

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

23 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rock Creek Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Varga, MD

Role: PRINCIPAL_INVESTIGATOR

Star Scientific, Inc

Locations

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Comfort Inn

Martinsburg, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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RCP-002

Identifier Type: -

Identifier Source: org_study_id

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