Study to Evaluate the Safety and Efficacy of Dietary Supp... | NCT01428310

Studies
Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke

NCT01428310

Sponsor

Rock Creek Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Oct 30, 2015Estimated

Enrollment

109Actual

Phase

Phase 1

Conditions

Tobacco Use Disorder
Tobacco Dependence
Smoking

Interventions

Anatabloc(TM)
CigRx(R)

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

Sep 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Sep 1, 2011

First Submission Date that Met QC Criteria

Sep 1, 2011

First Posted Date

Sep 2, 2011Estimated

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

This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the effects of study product on a smoker's desire to smoke, measured by changes in scores on questionnaires given over time. Phase 2 will be a two-week extension, in which subjects will self-administer the study product and visit the study site for assessment of desire to smoke and collection of samples for the evaluation of smoking-related biomarkers.

Detailed Description

Not provided

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
Anatabloc(TM)	Active Comparator	dissolvable bit containing dietary ingredients, binders, fillers, and flavors	Dietary Supplement: Anatabloc(TM)
CigRx(R)	Active Comparator	dissolvable bit containing dietary ingredients, binders, fillers, and flavors	Dietary Supplement: CigRx(R)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anatabloc(TM)	Dietary Supplement	one dissolvable bit, one time, after a period of abstinence from smoking	Anatabloc(TM)

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	5 hours

Secondary Outcomes

Measure	Description	Time Frame
adverse events related to study product	collection of information on adverse events related to study product	5 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy adult smokers
using at least 1 pack of cigarettes per day, for at least 5 years

Exclusion Criteria:

allergy to study product 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	25404	United States

Condition Browse Module

MeSH Terms

ID	Term
D014029	Tobacco Use Disorder
D012907	Smoking

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided