A Pilot Study to Evaluate Safety and Efficacy of CigRx™ in Smokers
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ClinicalTrials.gov Identifier: NCT01262170 |
Recruitment Status
:
Completed
First Posted
: December 17, 2010
Last Update Posted
: October 30, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking Tobacco Use Disorder | Dietary Supplement: CigRx Lozenge Other: Tobacco Lozenge | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 109 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | April 2010 |

Arm | Intervention/treatment |
---|---|
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
|
- Effect on subject's craving to smoke [ Time Frame: 4 hours ]craving is assessed by changes in questionnaire answers over time
- Collection of information on adverse events related to study products [ Time Frame: 5 hours ]

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Ages Eligible for Study: | 23 Years to 72 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262170
United States, West Virginia | |
Comfort Inn | |
Martinsburg, West Virginia, United States, 25401 |
Principal Investigator: | Maria Varga, MD | Star Scientific, Inc |
Responsible Party: | Rock Creek Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01262170 History of Changes |
Other Study ID Numbers: |
RCP-002 |
First Posted: | December 17, 2010 Key Record Dates |
Last Update Posted: | October 30, 2015 |
Last Verified: | October 2015 |
Keywords provided by Rock Creek Pharmaceuticals, Inc.:
dietary supplement nutraceutical |
Additional relevant MeSH terms:
Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |