NCT01428310

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

1 month

First QC Date

September 1, 2011

Last Update Submit

October 29, 2015

Conditions

Tobacco Use DisorderTobacco DependenceSmoking

Keywords

dietary supplementnutraceutical

Outcome Measures

Primary Outcomes (1)

  • effect on subject's craving to smoke

    craving is assessed by changes in questionnaire answers over time

    5 hours

Secondary Outcomes (1)

  • adverse events related to study product

    5 hours

Study Arms (2)

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

Anatabloc(TM)DIETARY_SUPPLEMENT

one dissolvable bit, one time, after a period of abstinence from smoking

Anatabloc(TM)
CigRx(R)DIETARY_SUPPLEMENT

one dissolvable bit, one time, after a period of abstinence from smoking

CigRx(R)

Eligibility Criteria

Age23 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • allergy to study product components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comfort Inn

Martinsburg, West Virginia, 25404, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmoking

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Maria Varga, MD

    Star Scientific, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 2, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

October 30, 2015

Record last verified: 2015-10

Locations

US(1)