e-Cigarettes Versus NRT Gum for Smoking Cessation

December 10, 2015 updated by: Creighton University

e-Cigarettes Versus Nicotine Replacement Therapy for Smoking Cessation

This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for smoking cessation. Participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt. All participants will have a one hour meeting with a tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be determined at 12 weeks after the quit date. Continued use of nicotine replacement (either e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be evaluated.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68178
        • Creighton University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Smokes at least five cigarettes per day
  • No current or previous regular use of e-cigarettes
  • Ready to quit smoking

Exclusion Criteria:

  • Use of smokeless or pipe tobacco
  • Smoke more than 40 cigarettes per day
  • Pregnant or breastfeeding
  • Unable to chew gum due to dental or jaw problems
  • Myocardial infarction (heart attack) within the previous 12 months
  • Hypersensitivity to propylene glycol or nicotine gum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: e-Cigarette
STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
Other: STAM 1100mAh CE4 eGo Clearomizer
Other Names:
  • electronic nicotine delivery device
  • e-Cigarette
ACTIVE_COMPARATOR: Nicotine polacrilex
Nicotine Replacement gum
Drug: Nicotine polacrilex
2 mg and 4 mg gum will be used according to the FDA approved product labelling
Other Names:
  • Nicotine Gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Abstinence
Time Frame: 12 weeks
No smoking at 12 weeks after the predetermined quit date with a 5 day grace period. Self-report will be biochemically confirmed with expired carbon monoxide (CO) and salivary cotinine.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point Prevalence Abstinence
Time Frame: 12 weeks
No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Investigators

  • Principal Investigator: Amy J Arouni, MD, Creighton University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

August 16, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (ESTIMATE)

August 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2016

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-16684

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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