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

Primary Purpose

Smoking, Tobacco Use Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CigRx Lozenge
Tobacco Lozenge
Sponsored by
Rock Creek Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring dietary supplement, nutraceutical

Eligibility Criteria

23 Years - 72 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Comfort Inn

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CigRx Lozenge

Tobacco Lozenge

Arm Description

CigRx Lozenge

Tobacco Lozenge

Outcomes

Primary Outcome Measures

Effect on subject's craving to smoke
craving is assessed by changes in questionnaire answers over time

Secondary Outcome Measures

Collection of information on adverse events related to study products

Full Information

First Posted
December 15, 2010
Last Updated
October 29, 2015
Sponsor
Rock Creek Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01262170
Brief Title
A Pilot Study to Evaluate Safety and Efficacy of CigRx™ in Smokers
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rock Creek Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Tobacco Use Disorder
Keywords
dietary supplement, nutraceutical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CigRx Lozenge
Arm Type
Experimental
Arm Description
CigRx Lozenge
Arm Title
Tobacco Lozenge
Arm Type
Active Comparator
Arm Description
Tobacco Lozenge
Intervention Type
Dietary Supplement
Intervention Name(s)
CigRx Lozenge
Intervention Description
lozenge made of dietary supplements
Intervention Type
Other
Intervention Name(s)
Tobacco Lozenge
Intervention Description
lozenge made of compressed cured tobacco extract
Primary Outcome Measure Information:
Title
Effect on subject's craving to smoke
Description
craving is assessed by changes in questionnaire answers over time
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Collection of information on adverse events related to study products
Time Frame
5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Varga, MD
Organizational Affiliation
Star Scientific, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comfort Inn
City
Martinsburg
State/Province
West Virginia
ZIP/Postal Code
25401
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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