NCT00715871

Brief Summary

The purpose of this study is to determine whether the Smoke-Break nicotine delivery device can help smokers quit smoking, while avoiding many of the side effects associated with other smoking cessation products.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

February 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

5 months

First QC Date

July 8, 2008

Last Update Submit

November 17, 2014

Conditions

Smoking

Keywords

smokingsmoke cessationstop smokingquit smokingnicotine replacement therapySmoke Breakliquid cigaretteliquid nicotine cigarette

Outcome Measures

Primary Outcomes (1)

  • Smoke cessation

    12 weeks

Secondary Outcomes (1)

  • Side effects

    0-12 weeks

Study Arms (1)

Active Smokers

EXPERIMENTAL

Active smokers who used the Smoke-Break nicotine delivery device in an attempt to quit smoking cigarettes.

Drug: NicotineDevice: Smoke-Break nicotine delivery device

Interventions

NicotineDRUG

Subjects received an amount of "liquid nicotine cigarettes" (containing 1.5mg of nicotine each) based on the amount of nicotine the subjects had been receiving from cigarettes. The number of "liquid nicotine cigarettes" received by each subject was reviewed, and adjusted (if necessary), every two weeks for the duration of the 12-week study.

Also known as: Smoke-Break, liquid cigarette, liquid nicotine cigarette
Active Smokers
Smoke-Break nicotine delivery deviceDEVICE

The Smoke-Break nicotine delivery device is a "liquid nicotine cigarette" designed to mimic the act of smoking. It is an NRT (nicotine replacement therapy) similar in concept to the nicotine patch, gum, and lozenge, except the nicotine is delivered in a way designed to duplicate the cigarette smoking experience. The Smoke-Break nicotine delivery device is non-invasive.

Also known as: Smoke-Break, liquid cigarette, liquid nicotine cigarette
Active Smokers

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer is at least 18 years of age.
  • Volunteer currently smokes cigarettes, cigars or other forms of tobacco products for at least one year.
  • Volunteer wants to quit smoking.
  • Volunteer will be fully informed as to the nature of the study.
  • Volunteer will have no known allergy to any product ingredients as listed in the informed consent.
  • Volunteer agrees to a confidential pretest questionnaire and periodic monitoring as to the effectiveness of the smoking cessation regimen.
  • Volunteers are not currently using another nicotine replacement therapy.
  • Volunteer will agree to use birth control measures while on the study.

You may not qualify if:

  • Volunteer has a known allergy or hypersensitivity to nicotine or other related ingredients as outlined in the informed consent.
  • Volunteer does not desire to quit smoking.
  • Volunteer is using another nicotine replacement therapy.
  • Volunteer is pregnant or breast-feeding.
  • Volunteer has a history of heart disease or advanced diabetes.
  • Volunteer indicates on the application that they smoke ten (10) or fewer cigarettes per day.
  • Volunteer is using a daily prescription medicine for depression or asthma.
  • Volunteer is using a non-nicotine smoke cessation drug, such as Zyban or Chantix.
  • Volunteer is an employee of Smoke-Break Inc., or is personally known to an employee of Smoke-Break Inc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tommy G. Thompson Youth Center

West Allis, Wisconsin, 53214, United States

Location

Related Publications (1)

  • Geimer N, Olson CE, Baumgarten D, Kepner JL, Mahoney MC. Use of a liquid nicotine delivery product to promote smoking cessation. BMC Public Health. 2010 Mar 24;10:155. doi: 10.1186/1471-2458-10-155.

    PMID: 20334673DERIVED

MeSH Terms

Conditions

SmokingSmoking Cessation

Interventions

Nicotine

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Nicholas Geimer, MD

    Smoke-Break, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 15, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

US(1)