A Pilot Study to Evaluate Safety and Efficacy of CigRx™ i... | NCT01262170

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

NCT01262170

Sponsor

Rock Creek Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Oct 30, 2015Estimated

Enrollment

109Actual

Phase

Phase 1

Conditions

Smoking
Tobacco Use Disorder

Interventions

CigRx Lozenge
Tobacco Lozenge

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Dec 15, 2010

First Submission Date that Met QC Criteria

Dec 16, 2010

First Posted Date

Dec 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2015

Last Update Posted Date

Oct 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

109Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CigRx Lozenge	Experimental	CigRx Lozenge	Dietary Supplement: CigRx Lozenge
Tobacco Lozenge	Active Comparator	Tobacco Lozenge	Other: Tobacco Lozenge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CigRx Lozenge	Dietary Supplement	lozenge made of dietary supplements	CigRx Lozenge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect on subject's craving to smoke	craving is assessed by changes in questionnaire answers over time	4 hours

Secondary Outcomes

Measure	Description	Time Frame
Collection of information on adverse events related to study products		5 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Years

Maximum Age

72 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Varga, MD	Star Scientific, Inc	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Comfort Inn		Martinsburg	West Virginia	25401	United States

Condition Browse Module

MeSH Terms

ID	Term
D012907	Smoking
D014029	Tobacco Use Disorder

Ancestor Terms

ID	Term
D001519	Behavior
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided