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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Rock Creek Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT01262170

First received: December 15, 2010

Last updated: October 23, 2014

Last verified: October 2014

History of Changes

Purpose

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

Condition	Intervention	Phase
Smoking Tobacco Use Disorder	Dietary Supplement: CigRx Lozenge Other: Tobacco Lozenge	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Active-Controlled, Crossover, Pilot Study to Evaluate the Safety and Efficacy of CigRx™ Lozenge, a Non-Nicotine Non-Tobacco Dietary Supplement, in Daily Smokers in Temporarily Reducing the Desire to Smoke

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Smoking

U.S. FDA Resources

Further study details as provided by Rock Creek Pharmaceuticals, Inc.:

Primary Outcome Measures:

Effect on subject's craving to smoke [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
craving is assessed by changes in questionnaire answers over time

Secondary Outcome Measures:

Collection of information on adverse events related to study products [ Time Frame: 5 hours ] [ Designated as safety issue: No ]


Enrollment:	109
Study Start Date:	April 2010
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CigRx Lozenge CigRx Lozenge	Dietary Supplement: CigRx Lozenge lozenge made of dietary supplements
Active Comparator: Tobacco Lozenge Tobacco Lozenge	Other: Tobacco Lozenge lozenge made of compressed cured tobacco extract

Detailed 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.

Eligibility


Ages Eligible for Study:	23 Years to 72 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262170

Locations


United States, West Virginia
Comfort Inn
Martinsburg, West Virginia, United States, 25401

Sponsors and Collaborators

Rock Creek Pharmaceuticals, Inc.

Investigators


Principal Investigator:	Maria Varga, MD	Star Scientific, Inc

More Information

No publications provided


Responsible Party:	Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01262170 History of Changes
Other Study ID Numbers:	RCP-002
Study First Received:	December 15, 2010
Last Updated:	October 23, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Rock Creek Pharmaceuticals, Inc.:


dietary supplement nutraceutical

Additional relevant MeSH terms:


Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

ClinicalTrials.gov processed this record on March 03, 2015

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